FDA Adverse Event
Malfunction
Summary report: N
AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS
MDR report key: 4131187
·
Received October 1, 2014
Report
- Report Number
- 3003433498-2014-00198
- Event Type
- Malfunction
- Date Received
- October 1, 2014
- Report Date
- September 12, 2014
- Manufacturer
- INVACARE CONTINUING CARE
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
PER THE DEALER, BOTH CASTER TYPES ARE FAILING AROUND THE VERTICAL ACCESS AND WONT SPIN AROUND THE VERTICAL ACCESS AND THEN THEY HIT THE FRAME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 612709 | AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS | 880.5100 | FNL | INVACARE CONTINUING CARE | IHCS9FX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |