MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-02-26 for PERI-PRO 90000 * manufactured by Air Techniques, Inc..
[1067726]
X-ray film developer was in use when staff noticed thick black smoke coming out of the top vent area of developer. The electrical plug was immediately removed from the wall. Right after that flames burst out of the machine. The flames reached about a foot and a half high. Staff used a blanket and a fire extinguisher to put out the fire. Staff involved complained of some minor irritation from breathing the smoke. Later analysis of the device revealed the fan had failed and the thermal safety fuse was improperly wired in a way that bypassed it. The miswiring is most likely a result of an improper repair done by the hospital at some time in the past. The design of the device makes miswiring a fairly easy mistake as there are many interchangeable connection points. Even if the thermal safety fuse is intact, there is the possibility for pieces of film to fall directly onto the heating element.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1327706 |
| MDR Report Key | 1327706 |
| Date Received | 2009-02-26 |
| Date of Report | 2009-02-26 |
| Date of Event | 2009-02-06 |
| Report Date | 2009-02-26 |
| Date Reported to FDA | 2009-02-26 |
| Date Added to Maude | 2009-03-03 |
| 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 | PERI-PRO |
| Generic Name | FILM PROCESSOR, DENTAL X-RAY |
| Product Code | EGY |
| Date Received | 2009-02-26 |
| Model Number | 90000 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Device Age | 8 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AIR TECHNIQUES, INC. |
| Manufacturer Address | 1295 WALT WHITMAN ROAD MELVILLE NY 11747 US 11747 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-02-26 |