MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2014-09-09 for PERI-PRO 94000M 94000 manufactured by Air Techniques, Inc..
[4697857]
On (b)(6) 2012, a psa representative (distributor) emailed air techniques to report an issue with a peri-pro. While a (b)(6) service representative was at a customer's site (lifetime dental solutions), he was asked to replaced a heater pad. After replacing the heater pad, the service rep left the room. He was then immediately alerted by the staff that the peri-pro unit was smoking. There were no injuries or health hazard reported. This peri-pro iii ((b)(4), date of manufacture 10/26/2005) was sold to (b)(6). The unit was installed in (b)(6) at lifetime dental solutions and has been in service for seven years. (b)(6) dental service technician confirmed that there were no injuries. This incident is being deemed an adulteration by the customer. This investigation was conducted from information and pictures received from (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2428225-2014-00002 |
| MDR Report Key | 4105450 |
| Report Source | 08 |
| Date Received | 2014-09-09 |
| Date of Report | 2014-09-09 |
| Date of Event | 2012-08-27 |
| Device Manufacturer Date | 2005-10-26 |
| Date Added to Maude | 2014-09-29 |
| 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 | 2014-09-09 |
| 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 | R |
| 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 | 2014-09-09 |