FDA Adverse Event
Malfunction
Summary report: N
XPO W/SUPPLEMENTAL BATTERY 9153648167
MDR report key: 4820896
·
Received June 5, 2015
Report
- Report Number
- 1031452-2015-14183
- Event Type
- Malfunction
- Date Received
- June 5, 2015
- Report Date
- May 1, 2015
- Manufacturer
- INVACARE FLORIDA OPERATIONS
- Product Code
- CAW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS RETURNED FOR EVALUATION. FAILURE MODES: MANIFOLD 1152813 HOSE LEAKING, MANIFOLD (B)(4) HOSE LEAKING, SIEVE BED XPOPOUR SATURATED ALARM MALFUNCTION NOT ADDRESSED IN EVALUATION.
Additional Manufacturer Narrative · 1
AN UPDATE WILL BE PROVIDED IF MORE INFORMATION IS OBTAINED.
Description of Event or Problem · 1
THE CONSUMER STATED THE UNIT IS SHUTTING DOWN. HE STATES THAT HE DOES NOT SEE ANY ALARMS. THE CONSUMER HAS OTHER MEANS OF O2. NO INJURY OR PROPERTY DAMAGE.
Description of Event or Problem · 1
THE CONSUMER STATED THE UNIT IS SHUTTING DOWN. HE STATES THAT HE DOES NOT SEE ANY ALARMS. THE CONSUMER HAS OTHER MEANS OF O2. NO INJURY OR PROPERTY DAMAGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 364401 | XPO W/SUPPLEMENTAL BATTERY 9153648167 | GENERATOR, OXYGEN, PORTABLE | CAW | INVACARE FLORIDA OPERATIONS | XPO100B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |