FDA Adverse Event
Malfunction
Summary report: N
PRECSION MEDICAL INC.
MDR report key: 3381555
·
Received September 4, 2013
Report
- Report Number
- 2523148-2013-00004
- Event Type
- Malfunction
- Date Received
- September 4, 2013
- Date of Event
- August 14, 2013
- Report Date
- September 4, 2013
- Manufacturer
- PRECISION MEDICAL INC.
- Product Code
- NFB
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
REPORTED THAT THERE WAS A FIRE WITH A CONSERVER. NO REPORTABLE INJURIES, BUT FIRE AND SMOKING DAMAGE, TO DWELLING. PHOTOS OF CONSERVER WERE SENT, SHOWING FIRE DAMAGE, BUT THE CONSERVER AND TANKS HAVE NOT BEEN INSPECTED BY US.
Description of Event or Problem · 1
FIRE INVOLVING A OXYGEN CONSERVER AND OXYGEN TANKS. PATIENT (B)(6) WAS SLIGHTLY INJURED, DID NOT REQUIRE MEDICAL ATTENTION. TRAILER HAD FIRE AND SMOKE DAMAGE. AT THIS TIME UNKNOWN CAUSE FOR THE FIRE, EVIDENCE INDICATES POSSIBLE SMOKING BY PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 439353 | PRECSION MEDICAL INC. | OXYGEN CONSERVER | NFB | PRECISION MEDICAL INC. | EP5 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |