MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2016-08-12 for ARK-10000 N/A manufactured by Nidek Co., Ltd.
[52122326]
In-house service evaluation activities review: the device was returned to nidek inc and in-house service engineer (se) evaluated the device on august 3, 2016 and was not able to duplicate or verify the smoke coming out from the device. No burnt component and/or part observed during visual inspection. Se tested the device and observed the following issues: main switch flips back to "off" position as soon as the device was turned "on". One of the three xyz motors was out from the bracket and all three ln screws were unscrewed from the motor bracket. All three screws were found in the bottom of the sbc assembly. Se determined that the main switch was turning back to "off" position due to short circuit inside the joystick assembly. Se replaced the joystick assembly (part #32164-2200) including the joystick circuit board (part #32164-ba04) but observed system turns "on" intermittently. Se replaced the device's motherboard (part #32166-ea38) which resolved the intermittent power "on" issue but the measurement head was not moving up/down. Se tested with a new main board (part #32164-ba01) but the measurement head was not moving up/down. Lastly, se replaced xyz motor (part # 32164-ea43) along with the main board and performed ar/ct calibration. After all affected parts replacements, the device functioned properly. Se determined that the probable cause for the reported complaint was inconclusive. There was no evidence of a burnt component/part found but may have likely associated with a short circuited joystick assembly unit that eventually caused the main board and the motherboard to go bad. Also, se determined that the three ln screws from the xyz motor was out from the bracket were due to overtime used. The device has been operational for 8 years, the user facility first owned the device since july 2008 and has had 5 service calls. However, after reviewing the service calls records, there was no record of the affected parts being replaced. Since device malfunctioned or not working as intended occurred, nidek inc considers this issue as a reportable event which there is more than a remote chance that a recurrence of the malfunction would cause or contribute to serious injury.
Patient Sequence No: 1, Text Type: N, H10
[52122327]
On (b)(6) 2016, customer called nidek inc to report that their ark-10000, opd-scan refractive power/corneal analyzer device serial# (b)(4) when powering on, they smell smoke coming from the head. Due to smoke coming from the head of the opd, customer was unable to use device until it is repaired. No patient injury reported from (b)(6) and requested service repair. No patient information needed as this mdr had no adverse event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002807715-2016-00032 |
| MDR Report Key | 5873189 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-08-12 |
| Date of Report | 2016-08-12 |
| Date of Event | 2016-07-14 |
| Device Manufacturer Date | 2002-02-28 |
| Date Added to Maude | 2016-08-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. PREETI BHATIA |
| Manufacturer Street | 47651 WESTINGHOUSE DRIVE |
| Manufacturer City | FREMONT CA 945397474 |
| Manufacturer Country | US |
| Manufacturer Postal | 945397474 |
| Manufacturer Phone | 5103537785 |
| Manufacturer G1 | NIDEK CO.,LTD |
| Manufacturer Street | 34-14 HIROISHI |
| Manufacturer City | GAMAGORI, AICHI, JPN 4430038 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 4430038 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARK-10000 |
| Generic Name | OPD SCAN, REFRACTIVE POWER/CORNEAL ANALYZER |
| Product Code | HKO |
| Date Received | 2016-08-12 |
| Model Number | ARK-10000 |
| Catalog Number | N/A |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NIDEK CO., LTD |
| Manufacturer Address | 34-14 HIROISHI GAMAGORI, AICHI, JPN 443-0038 JA 443-0038 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-08-12 |