FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE BARIATRIC BED
MDR report key: 3932172
·
Received April 3, 2014
Report
- Report Number
- 1824206-2014-01090
- Event Type
- Malfunction
- Date Received
- April 3, 2014
- Date of Event
- March 7, 2014
- Report Date
- March 7, 2014
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- PMA / PMN Number
- K122473
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN FOUND DURING A BETWEEN PATIENT INSPECTION THE LEFT REAR, RIGHT FRONT, AND THE RIGHT REAR BRAKE CASTERS WOULD NOT HOLD AS THEY WERE OUT OF ADJUSTMENT FROM NORMAL WEAR AND TEAR. THE TECHNICIAN ADJUSTED THE REAR BRAKE CASTERS AND THE RIGHT FRONT BRAKE CASTER TO RESOLVE THE ISSUE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.
Description of Event or Problem · 1
THE TECHNICIAN REPORTED THE REAR BRAKE CASTERS AND THE RIGHT FRONT BRAKE CASTERS WOULD NOT HOLD. 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 |
|---|---|---|---|---|---|---|---|
| 200649 | TOTALCARE BARIATRIC BED | A/C POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | 1840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |