MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-11-15 for BOOD FLOW METER TRANSONIC * manufactured by Transonic Systems, Inc..
[32304]
Md using cautery. Flow unit started to emit smoke, sparks and fumes. Unit removed. Failure apparently caused by a "short" in a ceramic capacitor. Flow meter was left plugged in while cautery in use. Mfr instructions state to turn off flow meter when not in use to prevent problems of this sort.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4001715 |
| MDR Report Key | 51967 |
| Date Received | 1996-11-15 |
| Date of Report | 1996-11-10 |
| Date of Event | 1996-08-23 |
| Date Added to Maude | 1996-12-02 |
| 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 | 0 |
| 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 | BOOD FLOW METER |
| Generic Name | BLOOD FLOW UNIT |
| Product Code | DPW |
| Date Received | 1996-11-15 |
| Model Number | TRANSONIC |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 52621 |
| Manufacturer | TRANSONIC SYSTEMS, INC. |
| Manufacturer Address | 34 DUTCH MILL RD ITHICA NY 14850 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1996-11-15 |