FDA Adverse Event
Malfunction
Summary report: N
MARK 5 NUVO
MDR report key: 1627260
·
Received March 4, 2010
Report
- Report Number
- 1039215-2010-00002
- Event Type
- Malfunction
- Date Received
- March 4, 2010
- Date of Event
- February 21, 2010
- Report Date
- March 5, 2010
- Manufacturer
- NIDEK MEDICAL PRODUCTS, INC.
- Product Code
- CAW
- PMA / PMN Number
- K040892
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DEVICE HAS BEEN RETURNED AND VERIFIED THAT AN ELECTRICAL PROBLEM DID CAUSE THE SMOKE INVOLVED IN THE INCIDENT. AN PLAN IS BEING DEVELOPED FOR EVAL BY COMPONENT MANUFACTURERS AND/OR INDEPENDENT PARTIES.
Description of Event or Problem · 1
NURSE WALKING DOWN THE HALFWAY OF THE NURSING HOME SMELLED SMOKE AND OBSERVED SMOKE IN ROOM (B)(6). RESIDENTS IN THE ROOM WERE REMOVED AS WERE RESIDENTS IN NEARBY ROOMS (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MARK 5 NUVO | GENERATOR, OXYGEN PORTABLE | CAW | NIDEK MEDICAL PRODUCTS, INC. | 525 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |