MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-04-07 for MAICO MA27 SCREENING AUDIOMETER manufactured by Maico Diagnostics.
[463967]
Failure of maico ma27 screening audiometer. Attenuator was found to be defective and was replaced.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1038443 |
| MDR Report Key | 707597 |
| Date Received | 2006-04-07 |
| Date of Report | 2006-04-07 |
| Date of Event | 2006-01-16 |
| Date Added to Maude | 2006-05-05 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAICO MA27 SCREENING AUDIOMETER |
| Generic Name | SCREENING AUDIOMETER |
| Product Code | EWO |
| Date Received | 2006-04-07 |
| Model Number | MA27 |
| Catalog Number | MA27 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 696645 |
| Manufacturer | MAICO DIAGNOSTICS |
| Manufacturer Address | 7625 GOLDEN TRIANGLE DR EDEN PRAIRIE MN 55344 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-04-07 |