FDA Adverse Event
Malfunction
Summary report: N
XL BARIATRIC BED
MDR report key: 3844813
·
Received March 12, 2014
Report
- Report Number
- 1824206-2014-00824
- Event Type
- Malfunction
- Date Received
- March 12, 2014
- Date of Event
- February 12, 2014
- Report Date
- February 12, 2014
- Manufacturer
- HILL-ROM, INC.
- Product Code
- IOQ
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN FOUND DURING A BETWEEN PATIENT INSPECTION THE BRAKE CASTERS WERE NOT HOLDING WHILE IN BRAKE MODE MOST LIKELY DUE TO NORM 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 THE BRAKES WERE NOT HOLDING. THE BED WAS LOCATED IN THE HILL-ROM SERVICE CENTER. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 149254 | XL BARIATRIC BED | BARIATRIC BED | IOQ | HILL-ROM, INC. | 610B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |