FDA Adverse Event
Malfunction
Summary report: N
MARK 5 NUVO
MDR report key: 3786375
·
Received March 28, 2014
Report
- Report Number
- 1039215-2014-00002
- Event Type
- Malfunction
- Date Received
- March 28, 2014
- Date of Event
- February 18, 2014
- Report Date
- February 21, 2014
- Manufacturer
- NIDEK MEDICAL PRODUCTS, INC.
- Product Code
- CAW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE UNIT WAS REPAIRED BY NSH AND THE DEFECTIVE PART WAS RETURNED TO NIDEK MEDICAL FOR EVALUATION. A CUT/TORN GASKET IN THE AIR TRANSPORT SYSTEM INTERFERED WITH THE FUNCTION OF A VALVE IN THE ASSEMBLY.
Description of Event or Problem · 1
PATIENT COMPLAINED OF DIFFICULTY BREATHING AND WAS TAKEN TO THE ER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 185573 | MARK 5 NUVO | GENERATOR, OXYGEN, PORTABLE | CAW | NIDEK MEDICAL PRODUCTS, INC. | 905-003NSH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR |