MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-05-20 for WAVESCAN WAVEFRONT SYSTEM WS1 0070-0150 manufactured by Abbott Medical Optics.
[3500008]
The clinic reported that the system gave off a burning smell and smoke was observed coming from the computer.
Patient Sequence No: 1, Text Type: D, B5
[10843901]
The field service engineer evaluated the system at the customer location and found that the power supply had a burnt odor. The power supply was replaced and the system was tested and placed back into service. All pertinent information available to amo has been submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006695864-2013-00168 |
| MDR Report Key | 3120850 |
| Report Source | 05,06 |
| Date Received | 2013-05-20 |
| Date of Report | 2013-04-25 |
| Date of Event | 2013-04-25 |
| Date Mfgr Received | 2013-04-25 |
| Device Manufacturer Date | 2003-02-25 |
| Date Added to Maude | 2013-05-20 |
| 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 | 7142478598 |
| Manufacturer G1 | ABBOTT MEDICAL OPTICS INC. |
| Manufacturer Street | AMO MILPITAS 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 WS1 |
| Generic Name | REFRACTIVE MEASUREMENT |
| Product Code | HKO |
| Date Received | 2013-05-20 |
| Model Number | WS1 |
| Catalog Number | 0070-0150 |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-05-20 |