FDA Adverse Event
Malfunction
Summary report: N
INVACARE MOBILAIRE
MDR report key: 3063602
·
Received April 12, 2013
Report
- Report Number
- 2182215-2013-00002
- Event Type
- Malfunction
- Date Received
- April 12, 2013
- Date of Event
- February 5, 2012
- Report Date
- April 12, 2013
- Manufacturer
- GARDNER DENVER THOMAS INC.
- Product Code
- CAF
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
A FOLLOW UP 3500A WILL BE PROVIDED AFTER THE PRODUCT EVALUATION IS COMPLETED, A ROOT CAUSE HAS BEEN ESTABLISHED AND A PROPER CORRECTIVE ACTION HAS BEEN DETERMINED.
Description of Event or Problem · 1
CUSTOMER ALLEGES THAT THE PUMP IS NOT PUTTING OUT ENOUGH PSI. NO INJURY IS ALLEGED AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 158039 | INVACARE MOBILAIRE | NEBULIZER PUMP (CAF) | CAF | GARDNER DENVER THOMAS INC. | IRC607 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |