MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,07 report with the FDA on 2012-12-20 for WAVESCAN WAVEFRONT SYSTEM WS1 0070-0150 manufactured by Abbott Medical Optics.
[3101593]
The amo field service engineer returned the customer's wavescan computer to amo for evaluation into the computer not functioning. Service depot evaluated the computer and when the power supply was powered up, smoke was observed being emitted from the power supply and the computer was non functional.
Patient Sequence No: 1, Text Type: D, B5
[10388369]
The cause of the computer's power supply components failing and emitting smoke was not determined. The computer was repaired with a new power supply installed and was tested. The computer operated correctly following repair. All pertinent information available to amo has been submitted.?
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006695864-2012-00191 |
| MDR Report Key | 2882459 |
| Report Source | 00,07 |
| Date Received | 2012-12-20 |
| Date of Report | 2012-12-18 |
| Date of Event | 2012-08-14 |
| Date Mfgr Received | 2012-12-18 |
| Device Manufacturer Date | 2001-08-02 |
| Date Added to Maude | 2012-12-20 |
| 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 |
| Reporter Occupation | SERVICE AND TESTING PERSONNEL |
| 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 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 | 2012-12-20 |
| 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-12-20 |