FDA Adverse Event
Injury
Summary report: N
PRECISION MEDICAL INC.
MDR report key: 4474826
·
Received January 28, 2015
Report
- Report Number
- 2523148-2014-00002
- Event Type
- Injury
- Date Received
- January 28, 2015
- Manufacturer
- PRECISION MEDICAL, INC.
- Product Code
- BTI
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE IN QUESTION WAS A PRECISION MEDICAL INC. PM15F AIR COMPRESSOR MANUFACTURED IN 11/1998. UNK SERIAL NUMBER HOUR METER HAD 14,627. THE DEVICE WAS FOUND TO HAVE A ELECTRICAL MOTOR ISSUE WHEN RETURNED FOR SERVICE AFTER THIS INCIDENT, THE DEVICE WAS NOT RETURNED TO THE MANUFACTURED, BUT TO (B)(4), REPRESENTING THE OWNER PAN HANDLE HOME HEALTH INC. THE DEVICE WAS DISCARDED. AS THE MANUFACTURER, THE DEVICE IS WELL BY BEYOND THE LIFE EXPECTANCY OF 5 YEARS. BECAUSE THE DEVICE WAS DISCARDED, WE ARE NOT ABLE TO DETERMINE THE OPERATION/FAILURE OF THE DEVICE.
Description of Event or Problem · 1
(B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 65896 | PRECISION MEDICAL INC. | COMPRESSOR | BTI | PRECISION MEDICAL, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |