FDA Adverse Event
Malfunction
Summary report: N
CLINITRON RITEHITE BED
MDR report key: 3823202
·
Received February 27, 2014
Report
- Report Number
- 1824206-2014-00631
- Event Type
- Malfunction
- Date Received
- February 27, 2014
- Date of Event
- January 29, 2014
- Report Date
- January 29, 2014
- Manufacturer
- HILL-ROM, INC.
- Product Code
- INX
- PMA / PMN Number
- K964223
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECH FOUND THE BRAKE WAS SLIPPING DUE TO NORMAL WEAR AND TEAR. THE TECH REPLACED THE RIGHT HEAD BRAKE CASTER TO RESOLVE THE ISSUE. BASED ON THIS INFO, NO FURTHER CATION IS REQUIRED.
Description of Event or Problem · 1
THE TECHNICIAN REPORTED THAT WHILE PERFORMING A BETWEEN PT INSPECTION HE FOUND THE RIGHT HEAD BRAKE CASTER WAS NOT HOLDING. 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 |
|---|---|---|---|---|---|---|---|
| 122703 | CLINITRON RITEHITE BED | BED, AIR FLUIDIZED | INX | HILL-ROM, INC. | 0800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |