MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2014-09-08 for PERI-PRO 94000M 94000 manufactured by Air Techniques, Inc..
[20785492]
The distributor reported burning smell and smoke from an air techniques peri-pro film processor during a service call by one of their tech's after replacing the heater pad in the unit.
Patient Sequence No: 1, Text Type: D, B5
[20949993]
On (b)(6) 2013, a customer reported a peri-pro iii (p/n 94000m) dryer section overheated causing the fan and plastic cover to melt. There were no injuries or health hazard reported. Air techniques contacted dr (b)(6) office. (b)(6), an employee of dr. (b)(6) team, confirmed the reported incident. She said kodak size #2 film was stuck in the dryer section, lying on the heater grill, and started to smoke. The unit immediately shut off. Under normal operating conditions, film falling out of the dryer transport section onto the heater dryer grill will cause the film to melt. The melting produces a melted plastic smell, but no smoke or hazard was created.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2428225-2014-00001 |
| MDR Report Key | 4095494 |
| Report Source | 08 |
| Date Received | 2014-09-08 |
| Date of Report | 2014-09-05 |
| Date of Event | 2013-01-04 |
| Device Manufacturer Date | 2012-03-06 |
| Date Added to Maude | 2014-09-24 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 1295 WALT WHITMAN RD. |
| Manufacturer City | MELVILLE NY 11747 |
| Manufacturer Country | US |
| Manufacturer Postal | 11747 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERI-PRO |
| Generic Name | FILM PROCESSOR |
| Product Code | IXW |
| Date Received | 2014-09-08 |
| Model Number | 94000M |
| Catalog Number | 94000 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AIR TECHNIQUES, INC. |
| Manufacturer Address | MELVILLE NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-09-08 |