MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-12-23 for TRIAGLE BIOMEDICAL SCIENCES H-FWS manufactured by Triangle Biomedical Sciences.
[19233918]
The device was not being used and the flotation dish had been removed from the heating well. The heating unit had been accidentally turned on and the plastic frame of the device was starting to melt and smoke while it was positioned on a lab counter. Fortunately, a lab tech working in the area smelled the burning plastic and investigated. The device was unplugged and transported to our biomed dept for inspection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 10983 |
| MDR Report Key | 10983 |
| Date Received | 1993-12-23 |
| Date of Report | 1993-12-20 |
| Date of Event | 1993-12-15 |
| Date Facility Aware | 1993-12-15 |
| Report Date | 1993-12-20 |
| Date Reported to FDA | 1993-12-21 |
| Date Reported to Mfgr | 1993-12-21 |
| Date Added to Maude | 1994-01-21 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRIAGLE BIOMEDICAL SCIENCES |
| Generic Name | HISTOLOGY FLOATATION WORK STATION |
| Product Code | IDY |
| Date Received | 1993-12-23 |
| Model Number | H-FWS |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | NI |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | 3 MO |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 10983 |
| Manufacturer | TRIANGLE BIOMEDICAL SCIENCES |
| Manufacturer Address | DURHAM NC 27705 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1993-12-23 |