MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2012-11-20 for WAVESCAN ADVANCED CUSTOMVUE ACV 0070-1478 manufactured by Abbott Medical Optics.
[3047422]
The clinic reported that when they turned on the wavescan computer it would not boot up, and they observed a puff of smoke coming from the computer along with an electrical smell. The system was unplugged by the clinic and field service was called.
Patient Sequence No: 1, Text Type: D, B5
[10318807]
The amo field service engineer inspected the system at the customer location and found that the power supply was the cause of the system not booting up. The computer power supply was replaced and field service verified correct operation of the system after servicing. All pertinent information available to abbott medical optics has been submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006695864-2012-00179 |
| MDR Report Key | 2840437 |
| Report Source | 05,06,07 |
| Date Received | 2012-11-20 |
| Date of Report | 2012-10-24 |
| Date of Event | 2012-10-24 |
| Date Mfgr Received | 2012-10-24 |
| Device Manufacturer Date | 2006-12-06 |
| Date Added to Maude | 2012-11-20 |
| 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 | 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 MANUFACTUING 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 ADVANCED CUSTOMVUE |
| Generic Name | REFRACTIVE MEASUREMENT |
| Product Code | HKO |
| Date Received | 2012-11-20 |
| Model Number | ACV |
| Catalog Number | 0070-1478 |
| Operator | PHYSICIAN |
| 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 | 2012-11-20 |