FDA Adverse Event
Injury
Summary report: N
CYPRESS
MDR report key: 5089561
·
Received September 18, 2015
Report
- Report Number
- 1062191-2015-00002
- Event Type
- Injury
- Date Received
- September 18, 2015
- Date of Event
- July 25, 2015
- Report Date
- September 18, 2015
- Manufacturer
- INOVO, INC
- Product Code
- NFB
- PMA / PMN Number
- K020475
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE UNIT OM-501 OXYGEN CONSERVER AND OXYGEN CYLINDER WERE RETURNED TO THE MANUFACTURER 8/28/2015 AND 9/8/2015. THE CONSERVER UNIT WAS VISUALLY INSPECTED AND TESTED UNDER NORMAL CONDITIONS. THE UNIT SHOWED NO LEAK OR MALFUNCTION. ALL PORT OR BARBS WERE INSPECTED AND SHOWED NO SIGNS OF FLASH OR BURN MARK PENETRATION. THERE IS NO SEAL WASHER SUBMITTED AND THE TANK HAD RESIDUE ON THE VALVE WITH FLASH AND BURN MARKS.
Description of Event or Problem · 1
PATIENT DAUGHTER STATED SHE WAS CHANGING AN EMPTY TANK IN THE BACK SEAT OF HER CAR (NO DAMAGE TO CAR). THE OXYGEN CONSERVER AND TANK EXPERIENCE A FLASH FIRE. SHE EXPERIENCED BURNS TO HER LEFT HAND AND WENT TO BURN CENTER. SHE HAS SINCE RECOVERED AND REPORTS NO OTHER ISSUES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 618880 | CYPRESS | CONSERVER | NFB | INOVO, INC | OM-501 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Other |