FDA Adverse Event
Malfunction
Summary report: N
MECHANICAL (MANUAL) WHEELCHAIR
MDR report key: 3331283
·
Received September 6, 2013
Report
- Report Number
- 1525712-2013-07599
- Event Type
- Malfunction
- Date Received
- September 6, 2013
- Report Date
- August 28, 2013
- Manufacturer
- CHAMPION MANUFACTURING
- Product Code
- IOR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
(B)(4) - FOLLOW UP #001. INITIAL (B)(4) ISSUED MFR. REPORT # 1525712-2013-07599 INDICTING THE MANUFACTURER AS INVACARE TAYLOR STREET WHEN THE ACTUAL MANUFACTURER IS CHAMPION MANUFACTURING AND THE MODEL # WAS REPORTED AS A HTTR5500 WHEN IT IS ACTUALLY A HTR5500. . THE CORRECT FDA REGISTRATION # IS 1834066.
Description of Event or Problem · 1
PROVIDER STATES WHEN THE CLIENT LEANS BACK ON THE CHAIR IT DOES NOT LOCK AT ALL IT GOES ALL THE WAY BACK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 443089 | MECHANICAL (MANUAL) WHEELCHAIR | 890.3850 | IOR | CHAMPION MANUFACTURING | HTR5500 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |