MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2012-09-27 for WAVESCAN ADVANCED CUSTOMVUE ACV 0070-1478 manufactured by Abbott Medical Optics.
[2907904]
The customer reported that the computer would not boot up and the power supply emitted smoke when the computer was turned on.
Patient Sequence No: 1, Text Type: D, B5
[10136003]
Information in section f10 completed by the manufacturer. The field service engineer inspected the system at the customer location and observed that the computer''s power supply had a burnt smell and the video board had a faulty capacitor. The field service engineer replaced the system computer and verified the system operation following repair.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006695864-2012-00157 |
| MDR Report Key | 2763263 |
| Report Source | 06,07 |
| Date Received | 2012-09-27 |
| Date of Report | 2012-08-29 |
| Date of Event | 2012-08-29 |
| Date Mfgr Received | 2012-08-29 |
| Device Manufacturer Date | 2011-05-05 |
| Date Added to Maude | 2012-09-27 |
| 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 | 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 | 7142478985 |
| 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 | 2012-09-27 |
| 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 | 2012-09-27 |