FDA Adverse Event
Malfunction
Summary report: N
MECHANICAL CHAIR/TRANSPORT CHAIR
MDR report key: 2914517
·
Received January 14, 2013
Report
- Report Number
- 9616091-2013-00075
- Event Type
- Malfunction
- Date Received
- January 14, 2013
- Report Date
- January 14, 2013
- Manufacturer
- INVAMEX
- Product Code
- INM
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
(B)(4). IT WAS REPORTED BY THE FACILITY STAFF THAT THE 9XT MECHANICAL WHEELCHAIR PIVOT LINK WAS BROKEN. THERE WAS NO PATIENT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 20391 | MECHANICAL CHAIR/TRANSPORT CHAIR | 890.3100 | INM | INVAMEX | 9XT |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |