MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-12-17 for WAVESCAN FOURIER ALGORITHM 0070-1006 manufactured by Abbott Medical Optics.
[5176645]
Account reported the computer was not functioning and the power supply fans were not operating. Customer saw smoke coming from back of the computer upon powering up the wavescan for use. System shut down.
Patient Sequence No: 1, Text Type: D, B5
[12702253]
Field service specialist visited the account and smelled odor from enclosed power supply on computer. Replaced power supply assembly and tested the equipment. System meets amo specifications. All pertinent information available to abbott medical optics has been submitted. Placeholder.
Patient Sequence No: 1, Text Type: N, H10
[23244448]
Corrections: health professional is being corrected to yes for the initial medical device report (mdr). Health professional was not included in the initial mdr. Evaluation: operation problem for results is being corrected to power supply for the initial mdr. All pertinent information available to the abbott medical optics has been submitted.
Patient Sequence No: 1, Text Type: N, H10
[23244809]
All pertinent information available to abbott medical optics has been submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006695864-2014-00550 |
| MDR Report Key | 4338687 |
| Report Source | 05,06 |
| Date Received | 2014-12-17 |
| Date of Report | 2014-11-26 |
| Date of Event | 2014-11-26 |
| Date Mfgr Received | 2015-04-20 |
| Device Manufacturer Date | 2006-09-18 |
| Date Added to Maude | 2014-12-17 |
| 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 | MRS. VALERIE SEDZICKI |
| Manufacturer Street | 1700 EAST ST. ANDREW PLACE SA3M - C3051 |
| Manufacturer City | SANTA ANA CA 92705 |
| Manufacturer Country | US |
| Manufacturer Postal | 92705 |
| Manufacturer Phone | 7142478567 |
| Manufacturer G1 | ABBOTT MEDICAL OPTICS INC. |
| Manufacturer Street | 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 FOURIER ALGORITHM |
| Generic Name | REFRACTIVE MEASUREMENT |
| Product Code | HKO |
| Date Received | 2014-12-17 |
| Model Number | 0070-1006 |
| Catalog Number | 0070-1006 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2014-12-17 |