FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE
MDR report key: 1997959
·
Received January 31, 2011
Report
- Report Number
- 1824206-2011-00545
- Event Type
- Malfunction
- Date Received
- January 31, 2011
- Date of Event
- January 19, 2011
- Report Date
- January 19, 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
TECH - (B)(6) ALLEGES TOTALCARE SPORT BED HEAD HI/LO IS DRIFTING. CONFIRMED HEAD HI/LO IS DRIFTING. CPR IS WORKING. REPLACED HEAD HI/LO PIVIT VALUE, PROBLEM RESOLVED. NO INJURIES REPORTED BY ACCT. LOCATION OF BED PLANT OPDS.
Description of Event or Problem · 1
COMPLAINT ALLEGES THAT THE TOTALCARE SPORT BED HEAD HI/LO WAS DRIFTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TOTALCARE | AC POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | P1900G006209 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |