FDA Adverse Event
Malfunction
Summary report: N
BED, MANUAL
MDR report key: 3200550
·
Received July 1, 2013
Report
- Report Number
- 1031452-2013-01246
- Event Type
- Malfunction
- Date Received
- July 1, 2013
- Report Date
- June 7, 2013
- Manufacturer
- INVACARE FLORIDA OPERATIONS
- Product Code
- FNJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
THE PROVIDER REPORTED THE BRACKET ON THE HEAD SECTION OF THE 5310IVC BED IS BROKEN AT THE WELD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 299640 | BED, MANUAL | 880.5120 | FNJ | INVACARE FLORIDA OPERATIONS | 5310IVC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |