Margen
INSPECTION REPORT — PERIODIC INSPECTION OF AN IMPLANTED DEVICE Verification Station no. 14 — Vitoria-Gasteiz File: 2041/IP/08812 Date: 9 April 2041, 10:04 Inspector: Idoia Zabala Otxoa, implanted device technician, registration no. 3,117
1. PURPOSE
This report is drawn up for the purposes of the two-yearly periodic inspection to which implanted ocular prostheses are subject, that is, the artificial eyes that replace the retina and that the patient carries inside the skull. The inspection takes place every twenty-four months. Without a valid certificate, the manufacturer disables the device's night mode by firmware within seven days, and the entire device within ninety.
Attending party: Anselmo Bidart Rezola, baker, night shift, Hornos Belarde bakehouse on Calle Bastiturri. Clocks in at 3:40.
2. DEVICE IDENTIFICATION
Model declared by the attending party: Vitrea OS-3. Serial number read by contact reader: D-41-2887-Q. Date of implantation: 12 November 2033. Last favourable inspection: 4 April 2039, Station no. 6. Declared manufacturer: Vitrea Optics, S.A., in liquidation since 2 March 2037.
It is recorded that this inspector begins the day with forty-one assigned inspections, that internal protocol allows eleven minutes for each, and that the present file is the twelfth of the day.
3. TESTS CARRIED OUT
3.1. Acuity under normal lighting (400 lux): comfortably above the regulatory minimum. Reads line six of the chart at three metres.
3.2. Acuity under low lighting (2 lux, night mode active): above the minimum. The attending party distinguishes the four grey samples on the reference panel and orders them without error in eleven seconds.
3.3. Colour discrimination under low lighting: the attending party correctly identifies the six chips on the amber scale. He states, and this inspector transcribes it for its technical relevance, that he uses that scale daily to decide when to take the bread out: "the colour of bread at five in the morning doesn't look like anything you see in daylight".
3.4. Day/night switching latency: 0.4 seconds. Within tolerance.
3.5. Anchoring integrity and casing temperature: correct.
Technical conclusion of the tests: the device performs above every required minimum.
4. ANOMALY DETECTED
On entering the serial number into the national register, the system returns code NH-04: "manufacturer extinct; no entity on record responsible for recertification".
Article 11.2 of the inspection regulations settles this case in one line: a device with no living manufacturer to answer for it is a non-approvable device, and the appropriate outcome is unfavourable. The station's software offers two buttons. UNFAVOURABLE closes the file in eight minutes. OWNERSHIP INVESTIGATION opens a procedure which, in this inspector's experience, never takes less than three hours.
This inspector presses the second one, for the reason set out in the following section.
5. GROUNDS FOR THE OWNERSHIP INVESTIGATION
The serial prefix does not fit. Vitrea Optics numbered its units with the prefix V-, without exception, from 2029 onwards. The attending party's device bears the prefix D-41, which corresponds to the numbering of Dolmen Fotónica, S.L., a factory in Legutio still in operation.
On consulting the register's transfer history, it is on record that Vitrea Optics never manufactured the OS-3 model: in January 2033 it acquired a complete batch of 4,200 units already assembled by Dolmen Fotónica and marketed them under its own brand. This is a lawful practice and was, at the time, a common one.
It is also on record that on 17 June 2039, when Vitrea Optics had been in liquidation for two years and its patients were beginning to go dark, Dolmen Fotónica recertified 1,240 units from that batch under code RH-7, assuming the technical liability the extinct manufacturer could no longer assume. Device D-41-2887-Q appears on that list, position 604.
It is therefore established that the device had a responsible entity as of 17 June 2039 and that the attending party states he was not informed of this at any point in the twenty-one months elapsed.
6. OWNERSHIP OF THE RECERTIFICATION
The "applicant" field of file RH-7 does not say Dolmen Fotónica, nor does it give the name of any of the 1,240 patients.
It says: Mutua Panificadora del Norte.
The recertification of the 1,240 units was applied for and paid, at 38 euros per unit, by the mutual society to which the sector's bakehouses are affiliated, Hornos Belarde among them. The transaction appears in its 2039 accounts as "maintenance of the workforce's night vision capability".
Legal consequence, hereby recorded: the licence that keeps the attending party's eye switched on is in the name of his professional mutual society, not in his own. As long as the attending party remains affiliated, the device is approved. Should he cease to be a member — through dismissal, a change of sector or non-payment of his contribution — the device would revert to the status of extinct manufacturer and article 11.2 would apply.
The attending party states that he had no knowledge of this. He is informed that he may apply for individual transfer of the recertification, currently costing 1,420 euros, and that he has twenty-four months in which to do so.
6 bis. SCOPE OF RECERTIFICATION RH-7
This inspector records, should it be of interest to the Directorate General, that the batch acquired by Vitrea Optics in 2033 comprised 4,200 units and that the 2039 recertification reached 1,240. The remaining 2,960 still appear in the register under code NH-04.
The rulings issued by this station on devices with the D-41 prefix since June 2039 have been reviewed: twenty-six files, twenty-three of them unfavourable. In none of the twenty-three is there any record of a check for the existence of file RH-7. The form field that would allow it sits on the third tab of the software and does not appear in the abbreviated workflow.
Two of those twenty-three holders have been reached on the telephone number listed in their file. Both state that their device went dark and that they paid for individual transfer of the certificate: 1,420 euros one, 1,420 euros the other. Neither of them belonged to a sectoral mutual society. This inspector has no power to review final rulings on her own initiative and confines herself to placing the fact on record.
7. ANNEX I — PARTIAL TRANSCRIPT OF THE HEARING
At the attending party's request, the passages he asked to have placed on record are transcribed below.
Inspector: Were you aware that your eye was recertified by the mutual society? Attending party: No. I signed a paper at the bakehouse, in June, one of those from the green folder. We all signed it. They told us it was for the medical check-up. Inspector: Do you recall paying anything yourself for the recertification? Attending party: I've been paying that mutual fourteen euros a month for eleven years. I signed up when I started, at twenty-two. Inspector: I repeat that the device is approved until April 2043. Attending party: Right. Approved as long as I make bread.
8. RULING
In view of the tests in section 3, all of them passed, and the existence of a responsible entity being established in section 5 by recertification file RH-7 of 17 June 2039, it is ruled:
FAVOURABLE, valid until 9 April 2043.
It is placed on record in the file, for the purposes of future inspections, that ownership of the recertification lies with a third party other than the wearer, and that this circumstance is not on record as having been communicated to the wearer by either of the two entities involved.
The Directorate General is advised to consider imposing an obligation to notify the wearer of the identity of the holder of the recertification of his own device. This inspector has spent three hours and eleven minutes on this file and leaves seven of the day's forty-one inspections unresolved.
9. CLOSING NOTE
The report having been read to the attending party, he is offered the chance to add a final statement, transcribed here verbatim, with which the file is closed:
"I've paid that contribution on the first for eleven years and I'll pay May's on the first. Put in writing what happens to the eye the day they let me go."