MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2012-12-10 for WAVESCAN ADVANCED CUSTOMVUE ACV 0070-1478 manufactured by Abbott Medical Optics.
[2987834]
The customer reported that the system would not power on. The amo field service representative noted that while servicing the system the computer emitted a loud noise and smoke was observed coming from the computer power supply.
Patient Sequence No: 1, Text Type: D, B5
[10413784]
The amo field service representative evaluated the system at the customer location and verified the system would not turn on and observed smoke coming from the power supply. Field service replaced the computer and verified the system was operational to specifications following repair. All pertinent information available to amo has been submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006695864-2012-00187 |
| MDR Report Key | 2866539 |
| Report Source | 01,05,07 |
| Date Received | 2012-12-10 |
| Date of Report | 2012-11-11 |
| Date of Event | 2012-11-11 |
| Date Mfgr Received | 2012-11-11 |
| Device Manufacturer Date | 2008-05-05 |
| Date Added to Maude | 2012-12-10 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | CAROL KAIL |
| Manufacturer Street | 1700 EAST ST. ANDREW PLACE |
| Manufacturer City | SANTA ANA CA 92705 |
| Manufacturer Country | US |
| Manufacturer Postal | 92705 |
| Manufacturer Phone | 7142478598 |
| Manufacturer G1 | ABBOTT MEDICAL OPTICS INC. |
| Manufacturer Street | AMO MANUFACTURING 510 COTTONWOOD |
| Manufacturer City | MILPITAS CA 95035 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95035 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WAVESCAN ADVANCED CUSTOMVUE |
| Generic Name | REFRACTIVE MEASUREMENT |
| Product Code | HKO |
| Date Received | 2012-12-10 |
| Model Number | ACV |
| Catalog Number | 0070-1478 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT MEDICAL OPTICS |
| Manufacturer Address | SANTA ANA CA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-12-10 |