FDA Adverse Event
Malfunction
Summary report: N
TRANSPORT 20 IN X 16 IN 9153637574
MDR report key: 5032581
·
Received August 26, 2015
Report
- Report Number
- 1525712-2015-04394
- Event Type
- Malfunction
- Date Received
- August 26, 2015
- Report Date
- August 5, 2015
- Manufacturer
- INVACARE TAYLOR STREET
- Product Code
- IOR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
CLIENT REPORTED WHEELCHAIR COLLAPSED (BACK NOT STAYING UP) MAINTENANCE SERVICE ATTENDED AND FOUND FRAME TO HAVE SNAPPED UNDERNEATH SEATING. THE REA AZALEA IS THE SAME /SIMILAR TO THE SOLARA 3G WHICH IS MANUFACTURED AND/OR MARKETED BY INVACARE IN THE U.S. THIS ALLEGED INCIDENT OCCURRED IN THE (B)(6).
Description of Event or Problem · 1
CLIENT REPORTED WHEELCHAIR COLLAPSED (BACK NOT STAYING UP) MAINTENANCE SERVICE ATTENDED AND FOUND FRAME TO HAVE SNAPPED UNDERNEATH SEATING. THE REA AZALEA IS THE SAME /SIMILAR TO THE SOLARA 3G WHICH IS MANUFACTURED AND/OR MARKETED BY INVACARE IN THE U.S. THIS ALLEGED INCIDENT OCCURRED IN THE (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 566635 | TRANSPORT 20 IN X 16 IN 9153637574 | WHEELCHAIR, MECHANICAL | IOR | INVACARE TAYLOR STREET | SOLARA 3G |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |