MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-12-04 for WAVESCAN ADVANCED CUSTOMVUE ACV 0070-1478 manufactured by Abbott Medical Optics.
[2985898]
The customer reported that the system computer was powering up intermittently and after several attempts, a puff of smoke was noticed exiting the computer. The customer indicated that they did not observe any burnt components in the computer.
Patient Sequence No: 1, Text Type: D, B5
[10261408]
An amo field service representative evaluated the system at the customer location and found that the system would power up intermittently. Field service also noticed a smell of smoke coming from the computer power supply. Field service replaced the power supply in the computer, which restored the consistent power up capability. Field service verified the system was operational to specifications following the component replacement. All pertinent information available to amo has been submitted.?
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006695864-2012-00185 |
| MDR Report Key | 2856660 |
| Report Source | 05,06 |
| Date Received | 2012-12-04 |
| Date of Report | 2012-11-06 |
| Date of Event | 2012-11-06 |
| Date Mfgr Received | 2012-11-06 |
| Device Manufacturer Date | 2008-02-08 |
| Date Added to Maude | 2012-12-04 |
| 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 | 2012-12-04 |
| Model Number | ACV |
| Catalog Number | 0070-1478 |
| Operator | HEALTH 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 | 2012-12-04 |