FDA Adverse Event
Malfunction
Summary report: N
PORTABLE LIQUID OXYGEN UNIT (CYLINDER ONLY,OXYGEN ITSELF IS A DRUG)
MDR report key: 2832783
·
Received November 14, 2012
Report
- Report Number
- 1525712-2012-02142
- Event Type
- Malfunction
- Date Received
- November 14, 2012
- Report Date
- November 8, 2012
- Manufacturer
- UNKNOWN
- Product Code
- CAW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
(B)(4) - THE DEALER REPORTED THAT THE UNKNOWN MODEL AND SERIAL NUMBERS O2 CYLINDER WAS LEAKING. THERE WAS NO REPORTED PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PORTABLE LIQUID OXYGEN UNIT (CYLINDER ONLY,OXYGEN ITSELF IS A DRUG) | 868.5655 | CAW | UNKNOWN | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 94 | Other |