FDA Adverse Event
Malfunction
Summary report: N
CLINITRON RITEHITE BED
MDR report key: 3893534
·
Received February 14, 2014
Report
- Report Number
- 1824206-2014-00444
- Event Type
- Malfunction
- Date Received
- February 14, 2014
- Date of Event
- January 16, 2014
- Report Date
- January 16, 2014
- Manufacturer
- HILL-ROM INC
- Product Code
- INX
- PMA / PMN Number
- K964223
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN FOUND THE CAUSE WAS DUE TO NORMAL WEAR ON THE BRAKE CASTER. THE TECHNICIAN REPLACED THE FOOT LEFT 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 FOOT LEFT BRAKE CASTER NOT PREVENTING BED MOVEMENT WHEN THE BRAKE IS ENGAGED. THE BED IS 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 |
|---|---|---|---|---|---|---|---|
| 99296 | CLINITRON RITEHITE BED | BED, AIR FLUIDIZED | INX | HILL-ROM INC | 0800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |