FDA Adverse Event
Malfunction
Summary report: N
MARK 5 NUVO
MDR report key: 1494734
·
Received August 25, 2009
Report
- Report Number
- 1039215-2009-00003
- Event Type
- Malfunction
- Date Received
- August 25, 2009
- Date of Event
- July 26, 2009
- Report Date
- August 25, 2009
- Manufacturer
- NIDEK MEDICAL PRODUCTS, INC.
- Product Code
- CAW
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
REQUESTED THAT DEVICE BE RETURNED FOR EVALUATION ON (B)(4), 2009. FOLLOW-UP REQUEST WAS SENT ON (B)(4), 2009.
Description of Event or Problem · 1
"MACHINE CAUGHT FIRE WHILE ON USE WITH A CUSTOMER IN THE NIGHT. APPARENTLY, THE CUSTOMER DID NOT WAKE UP WHILE THE MACHINE CONTINUED TO BURN." "THE PATIENT GOT UP WHEN HIS ROOM FILLED WITH SMOKE. HE FOUND THE MACHINE WAS BURNING AND SO HE POURED WATER ON THE MACHINE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MARK 5 NUVO | GENERATOR, OXYGEN, PORTABLE - CAW | CAW | NIDEK MEDICAL PRODUCTS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |