FDA Adverse Event
Malfunction
Summary report: N
WAVESCAN WAVEFRONT SYSTEM WS1
MDR report key: 2882459
·
Received December 20, 2012
Report
- Report Number
- 3006695864-2012-00191
- Event Type
- Malfunction
- Date Received
- December 20, 2012
- Date of Event
- August 14, 2012
- Report Date
- December 18, 2012
- Manufacturer
- ABBOTT MEDICAL OPTICS
- Product Code
- HKO
- PMA / PMN Number
- K000327
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- SERVICE AND TESTING PERSONNEL
Narratives
Additional Manufacturer Narrative · 1
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.
Description of Event or Problem · 1
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | WAVESCAN WAVEFRONT SYSTEM WS1 | REFRACTIVE MEASUREMENT | HKO | ABBOTT MEDICAL OPTICS | WS1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |