FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE BARIATRIC BED
MDR report key: 3830228
·
Received May 12, 2014
Report
- Report Number
- 1824206-2014-01463
- Event Type
- Malfunction
- Date Received
- May 12, 2014
- Date of Event
- April 14, 2014
- Report Date
- April 14, 2014
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- PMA / PMN Number
- K122473
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN FOUND DURING A BETWEEN PATIENT INSPECTION THAT THE BRAKE CASTERS WERE WORN MOSTLY LIKELY DUE TO NORMAL WEAR AND TEAR. THE LEFT FOOT AND HEAD RIGHT BRAKE CASTERS WERE REPLACED TO RESOLVE THE ISSUE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.
Description of Event or Problem · 1
THE TECHNICIAN REPORTED THAT THE LEFT FOOT AND RIGHT HEAD 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 |
|---|---|---|---|---|---|---|---|
| 283354 | TOTALCARE BARIATRIC BED | A/C POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | 1840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |