FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE BARIATRIC BED
MDR report key: 3896347
·
Received May 20, 2014
Report
- Report Number
- 1824206-2014-01573
- Event Type
- Malfunction
- Date Received
- May 20, 2014
- Date of Event
- April 24, 2014
- Report Date
- April 24, 2014
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- PMA / PMN Number
- K122473
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN FOUND THE BRAKE CASTERS WERE WORN DUE TO NORMAL WEAR AND TEAR. THE TECHNICIAN REPLACED ALL BRAKE CASTERS TO RESOLVE THE ISSUE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.
Description of Event or Problem · 1
THE TECHNICIAN REPORTED THAT HE FOUND DURING A BETWEEN PATIENT INSPECTION THAT ALL BRAKE CASTERS WOULD NOT HOLD WHILE IN BRAKE MODE. THE BED WAS LOCATED IN THE HILL-ROM SERVICE CENTER. THERE WAS NO PATIENT/USER INJURY REPORTED. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 300827 | TOTALCARE BARIATRIC BED | A/C POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | 1840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |