FDA Adverse Event
Death
Summary report: N
MARK 5 NUVO LITE
MDR report key: 5905248
·
Received August 25, 2016
Report
- Report Number
- 1039215-2016-00001
- Event Type
- Death
- Date Received
- August 25, 2016
- Date of Event
- June 15, 2016
- Report Date
- July 25, 2016
- Manufacturer
- NIDEK MEDICAL PRODUCTS, INC.
- Product Code
- CAW
- PMA / PMN Number
- K123738
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PATIENT CODES WERE DERIVED FROM INFORMATION PROVIDED TO INOGEN BY THE PATIENT'S DAUGHTER AND DOCUMENTED IN INOGEN ICR NUMBER (B)(4). AS OF THIS REPORT DATE, THE UNIT HAS NOT BEEN RECEIVED FROM THE PATIENT'S FAMILY. DEVICE NOT RECEIVED.
Additional Manufacturer Narrative · 1
PATIENT AND DEVICE CODES WERE DERIVED FROM INFORMATION PROVIDED TO (B)(6) BY THE PATIENT'S DAUGHTER AND DOCUMENTED IN (B)(6). SINCE THE INITIAL REPORT, THE UNIT HAS BEEN RECEIVED FROM THE PATIENT'S FAMILY AND HAS BEEN EVALUATED. THE DEVICE WAS INVESTIGATED AND RESULTS WERE DOCUMENTED.
Description of Event or Problem · 1
(B)(4)
Description of Event or Problem · 1
(B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 555852 | MARK 5 NUVO LITE | GENERATOR, OXYGEN, PORTABLE | CAW | NIDEK MEDICAL PRODUCTS, INC. | 525IN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Death| H |