FDA Adverse Event
Malfunction
Summary report: N
HTR5500 HTR-DELUXE MODEL 5500 9153635378
MDR report key: 4370318
·
Received December 30, 2014
Report
- Report Number
- 1525712-2014-09012
- Event Type
- Malfunction
- Date Received
- December 30, 2014
- Report Date
- December 9, 2014
- Manufacturer
- INVACARE TAYLOR STREET
- Product Code
- FRK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
PART ON LEG IS BROKEN. EXCHANGED HTR CHAIR SKU 0131769 FOR SKU 013189 SERIAL NUMBER (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 860109 | HTR5500 HTR-DELUXE MODEL 5500 9153635378 | CHAIR AND TABLE, MEDICAL | FRK | INVACARE TAYLOR STREET | HTR5500 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |