MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-12-09 for TREMETRICS MODEL 757 AUDIOMETER manufactured by Tremetrics.
[1823599]
(b)(6), experienced the following problems with (b)(4) tremetrics model 757 audiometers: printers working sporadically, touch screen failures, headphone problems, software issues. An upgrade was performed on (b)(6) 2010 with a result of no correction of problems.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5018551 |
| MDR Report Key | 1927143 |
| Date Received | 2010-12-09 |
| Date of Report | 2010-12-09 |
| Date Added to Maude | 2010-12-21 |
| 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 | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TREMETRICS MODEL 757 AUDIOMETER |
| Generic Name | AUDIOMETER |
| Product Code | EWO |
| Date Received | 2010-12-09 |
| Model Number | 757 |
| Operator | OTHER |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TREMETRICS |
| Manufacturer Address | 7625 GOLDEN TRIANGLE DRIVE EDEN PRAIRE MN 55344 US 55344 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-12-09 |