MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-10-30 for WAVESCAN WAVEFRONT SYSTEM ACV 0070-1478 manufactured by Abbott Medical Optics.
[21754813]
The customer reported that when they turned on their system, smoke was observed coming out the back of the computer. The system was immediately turned off and disconnected.
Patient Sequence No: 1, Text Type: D, B5
[21886497]
An amo field service engineer inspected the system at the customer's location and did not observe any evidence of smoke or fire. The field service engineer found that the power supply board was not functioning and replaced the power supply board and also performed calibrations. The system met specifications following repair and was placed back into use. All pertinent information available to amo has been submitted.?
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006695864-2012-00173 |
| MDR Report Key | 2808978 |
| Report Source | 05,06 |
| Date Received | 2012-10-30 |
| Date of Report | 2012-10-04 |
| Date of Event | 2012-10-04 |
| Date Mfgr Received | 2012-10-04 |
| Device Manufacturer Date | 2006-12-29 |
| Date Added to Maude | 2012-10-30 |
| 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 DRIVE |
| 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 WAVEFRONT SYSTEM |
| Generic Name | REFRACTIVE MEASUREMENT |
| Product Code | HKO |
| Date Received | 2012-10-30 |
| Model Number | ACV |
| Catalog Number | 0070-1478 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT MEDICAL OPTICS |
| Manufacturer Address | SANTA ANA CA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-10-30 |