FDA Adverse Event
Death
Summary report: N
MARK 5 NUVO
MDR report key: 1356288
·
Received April 1, 2009
Report
- Report Number
- 1039215-2009-00001
- Event Type
- Death
- Date Received
- April 1, 2009
- Report Date
- March 31, 2009
- Manufacturer
- NIDEK MEDICAL PRODUCTS, INC.
- Product Code
- CAW
- PMA / PMN Number
- K032509
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
Narratives
Additional Manufacturer Narrative · 1
INITIAL REPORTER CONTACTED IN 2009 TO OBTAIN MISSING INFORMATION REGARDING EVENT. INITIAL REPORTER STATED, HE HAD NO RECOLLECTION OF THIS EVENT OR RECORDS OF IT, AND THAT HE WOULD HAVE REMEMBERED SOMETHING LIKE THIS. MANUFACTURER FOUND NO EVIDENCE THAT DEVICE CONTRIBUTED TO THE EVENT.
Description of Event or Problem · 1
"RUNNING BUT NOT PUTTING OUT ANYTHING AND IS NOT ALARMING." PATIENT EXPIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MARK 5 NUVO | GENERATOR, OXYGEN, PORTABLE - CAW | CAW | NIDEK MEDICAL PRODUCTS, INC. | MARK5 NUVO/M5C5 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |