FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE
MDR report key: 2232646
·
Received July 19, 2011
Report
- Report Number
- 1824206-2011-03803
- Event Type
- Malfunction
- Date Received
- July 19, 2011
- Date of Event
- June 26, 2011
- Report Date
- June 26, 2011
- Manufacturer
- HILL-ROM INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ME, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN FOUND THE CPR VALVE WAS STICKING IN THE OPEN POSITION. THE TECHNICIAN REPLACED THE CPR VALVE TO REPAIR THE BED.
Description of Event or Problem · 1
THE ACCOUNT STATED THAT THE BED HAS A STICKING CPR VALVE WHICH IS PREVENTING THE HEAD SECTION FROM RISING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TOTALCARE | AC-POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM INC. | 1900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |