FDA Adverse Event
Malfunction
Summary report: N
CLINITRON RITEHITE BED
MDR report key: 3881495
·
Received February 19, 2014
Report
- Report Number
- 1824206-2014-00519
- Event Type
- Malfunction
- Date Received
- February 19, 2014
- Date of Event
- January 22, 2014
- Report Date
- January 22, 2014
- Manufacturer
- HILL-ROM INC.
- Product Code
- INX
- PMA / PMN Number
- K964223
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN FOUND THE CAUSE IS MOST LIKELY DUE TO NORMAL WEAR AND TEAR OF THE BRAKE CASTERS. THE TECHNICIAN REPLACED 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 RIGHT FRONT BRAKE CASTER IS NOT HOLDING. THE BED IS LOCATED IN THE HILL-ROM SERVICE CENTER. THERE WAS NO PT/USER INJURY REPORTED. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 104217 | CLINITRON RITEHITE BED | BED, AIR FLUIDIZED | INX | HILL-ROM INC. | 0800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |