FDA Adverse Event
Malfunction
Summary report: N
MARK 5 NUVO LITE
MDR report key: 3701552
·
Received February 25, 2014
Report
- Report Number
- 1039215-2014-00001
- Event Type
- Malfunction
- Date Received
- February 25, 2014
- Date of Event
- January 20, 2014
- Report Date
- February 25, 2014
- Manufacturer
- NIDEK MEDICAL PRODUCTS, INC.
- Product Code
- CAW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DISTRIBUTOR (B)(4) HAS BEEN CONTACTED TO REQUEST ADDITIONAL INFO AND RETURN OF THE CONCENTRATOR FOR INVESTIGATION.
Description of Event or Problem · 1
PT'S DAUGHTER STATED THAT CONCENTRATORS ARRIVED SMELLING "TOXIC" AND CAUSED HER MOTHER TO HAVE "DRY HEAVES" AND "BLACK OUT". HER MOTHER WAS REMOVED FROM HER HOME AND THE HOUSE WAS AIRED OUT. A REPLACEMENT UNIT WAS RECEIVED AND HER BROTHER "OPENED THE BOX AND IT SMELLED SO BAD. HE SAID HIS LUNGS WERE HURTING AFTER HE OPENED."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 116677 | MARK 5 NUVO LITE | GENERATOR, OXYGEN PORTABLE | CAW | NIDEK MEDICAL PRODUCTS, INC. | 525IN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR |