FDA Adverse Event
Malfunction
Summary report: N
AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS
MDR report key: 4131417
·
Received October 1, 2014
Report
- Report Number
- 3003433498-2014-00201
- Event Type
- Malfunction
- Date Received
- October 1, 2014
- Report Date
- September 11, 2014
- Manufacturer
- INVACARE CONTINUING CARE GROUP
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
(B)(4). IHCS3 - PER (B)(6) ALLEGED THAT THE LOCK OUT OF BOX IS NOT WORKING AT ALL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 611209 | AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS | 880.5100 | FNL | INVACARE CONTINUING CARE GROUP | IHCS3 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |