MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2009-04-08 for PERI-PRO 90000 manufactured by Air Techniques Inc.
[15159056]
In 2009, a complaint was received regarding a film processor which caught fire during operation at a user facility. The user facility stated that the nurse who witnessed the incident claimed there was no injury to any individual, staff, or patient. A month later, the user facility refused to divulge the patient or witness involved with this event in spite of several attempts to obtain this information. The user facility stated that they should not have to provide this information since no one was injured. The user facility also refused to provide us with the service history of the device. On 04/07/09, we were advised by an employee at the user facility that the device was in storage for an unknown length of time. The device was brought out of storage and used for approximately one day before the incident occurred.
Patient Sequence No: 1, Text Type: D, B5
[15173289]
Mdr investigation results: the complaints were reviewed for the peri pro i device since initial manufacturing date. No incidences were reported for this product. This device was found to have never been serviced by air techniques. The device history record was reviewed and found to be complete and the device was determined to meet engineering design requirement specifications. It appears that the cause of the incident was that the device was serviced by an unauthorized representative.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2428225-2009-00001 |
| MDR Report Key | 1426539 |
| Report Source | 06 |
| Date Received | 2009-04-08 |
| Date of Report | 2009-04-07 |
| Date of Event | 2009-03-08 |
| Date Mfgr Received | 2009-03-08 |
| Device Manufacturer Date | 1996-03-01 |
| Date Added to Maude | 2009-09-02 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | VINCENT VEGA |
| Manufacturer Street | 1295 WALT WHITMAN RD. |
| Manufacturer City | MELVILLE NY 11747 |
| Manufacturer Country | US |
| Manufacturer Postal | 11747 |
| Manufacturer Phone | 5162145512 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERI-PRO |
| Generic Name | FILM PROCESSOR, DENTAL X-RAY |
| Product Code | IXW |
| Date Received | 2009-04-08 |
| Returned To Mfg | 2009-04-06 |
| Model Number | 90000 |
| Catalog Number | 90000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2009-04-08 |