FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE
MDR report key: 2151277
·
Received June 7, 2011
Report
- Report Number
- 1824206-2011-03134
- Event Type
- Malfunction
- Date Received
- June 7, 2011
- Date of Event
- May 17, 2011
- Report Date
- May 17, 2011
- Manufacturer
- HILL-ROM INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE ACCOUNT MAINTENANCE STATED, THERE WAS PLAY FOR THE UP MOVEMENT OF EMERGENCY TREND PEDAL, BUT THE CPR HAD NO PLAY AND IT FELT LIKE MAY BE ACTIVATED. THE ACCOUNT REPLACED THE CPR VALVE TO REPAIR THE BED.
Description of Event or Problem · 1
THE ACCOUNT STATED THE HEAD SECTION OF THIS BED HAS A VERY SLOW DRIFT.
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 | UNK |