FDA Adverse Event
Injury
Summary report: N
MOBILAIRE
MDR report key: 217203
·
Received April 1, 1999
Report
- Report Number
- 1525712-1999-00022
- Event Type
- Injury
- Date Received
- April 1, 1999
- Date of Event
- March 1, 1999
- Report Date
- March 26, 1999
- Manufacturer
- INVACARE CORPORATION
- Product Code
- CAW
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
MANUFACTURER RECEIVED A REPORT STATING NO OXYGEN WAS BEING EMITTED FROM AN OXYGEN CONCENTRACTOR BECAUSE A HOSE HAD BECOME DISCONNECTED. THE PATIENT REQIURED CPR AND WAS HOSPITALIZED. EVALUATION BY THE MANUFACTURER HAS NOT BEEN PERMITTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MOBILAIRE | PORTABLE OXYGEN GENERATOR | CAW | INVACARE CORPORATION | 5 LITER CONCENTRATOR W/SENS | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Hospitalization |