MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-21 for PERIPRO-PERIOMAT 94000M manufactured by Air Techniques, Inc..
[117966413]
Customer reported a small fire with the 15 year old peripro iii device. It started smoking at the dryer end then progressed into flames. No service or maintenance has been done recently. Fire department and police arrived which was triggered by the alarm. There were no reports of injury. No other damages were reported other than the unit.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2428225-2018-00006 |
| MDR Report Key | 7802733 |
| Date Received | 2018-08-21 |
| Date of Report | 2018-08-20 |
| Date of Event | 2018-07-26 |
| Device Manufacturer Date | 2003-02-03 |
| Date Added to Maude | 2018-08-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JOSEPH LATKOWSKI |
| Manufacturer Street | 1295 WALT WHITMAN ROAD |
| Manufacturer City | MELVILLE NY 11747 |
| Manufacturer Country | US |
| Manufacturer Postal | 11747 |
| Manufacturer G1 | AIR TECHNIQUES INC. |
| Manufacturer Street | 1295 WALT WHITMAN ROAD |
| Manufacturer City | MELVILLE NY 11747 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 11747 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PERIPRO-PERIOMAT |
| Generic Name | PERIPRO III |
| Product Code | IXW |
| Date Received | 2018-08-21 |
| Returned To Mfg | 2018-08-21 |
| Model Number | 94000M |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AIR TECHNIQUES, INC. |
| Manufacturer Address | 1295 WALT WHIMAN ROAD MELVILLE NY 11747 US 11747 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-21 |