FDA Adverse Event
Malfunction
Summary report: N
MARK 5 NUVO
MDR report key: 2654495
·
Received June 29, 2012
Report
- Report Number
- 1039215-2012-00001
- Event Type
- Malfunction
- Date Received
- June 29, 2012
- Date of Event
- November 2, 2010
- Report Date
- June 28, 2012
- Manufacturer
- NIDEK MEDICAL PRODUCTS, INC.
- Product Code
- CAW
- PMA / PMN Number
- K040892
- Report Source
- Manufacturer report
- Reporter Location
- SF
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PHOTOGRAPH INDICATES FAILURE OF CAPACITOR BY THE PROXIMITY OF THE DAMAGE TO THE LOCATION OF THE CAPACITOR. CUSTOMER ALSO INDICATED THAT THE CAPACITOR HAD FAILED. CUSTOMER MISIDENTIFIED THE MODEL NUMBER AS 925 WHEN IT'S ACTUALLY 905.
Description of Event or Problem · 1
FAULTY CAPACITOR CAUSED FIRE, ONLY DEVICE DAMAGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MARK 5 NUVO | GENERATOR, OXYGEN PORTABLE | CAW | NIDEK MEDICAL PRODUCTS, INC. | 905 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR |