FDA Adverse Event
Malfunction
Summary report: N
AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS
MDR report key: 3955539
·
Received July 24, 2014
Report
- Report Number
- 3003433498-2014-00139
- Event Type
- Malfunction
- Date Received
- July 24, 2014
- Report Date
- June 16, 2014
- Manufacturer
- INVACARE CONTINUING CARE
- Product Code
- FNJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
CUSTOMER STATES THE FRAME HAS A CRACK IN IT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 434575 | AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS | 880.5100 | FNJ | INVACARE CONTINUING CARE | IHCS9FX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |