MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-02-25 for TRANSDUCER OT-4212D manufactured by Viggo Spectromed.
[1942]
Transducer failure straight out of pack before use - gold to gold tab failuredevice labeled for single use. Patient medical status prior to event: invalid data. Invalid data - regarding multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: visual examination. Results of evaluation: end of life - premature, mechanical problem. Conclusion: none or unknown. Certainty of device as cause of or contributor to event: yes. Corrective actions: device permanently removed from service. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4595 |
| MDR Report Key | 4595 |
| Date Received | 1993-02-25 |
| Date of Event | 1992-12-21 |
| Date Facility Aware | 1992-12-21 |
| Date Reported to Mfgr | 1992-12-23 |
| Date Added to Maude | 1993-05-28 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRANSDUCER |
| Product Code | BXO |
| Date Received | 1993-02-25 |
| Catalog Number | OT-4212D |
| Lot Number | 92AUG004 |
| Operator | OTHER |
| Device Availability | Y |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 4314 |
| Manufacturer | VIGGO SPECTROMED |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1993-02-25 |