FDA Adverse Event
Malfunction
Summary report: N
CLINITRON RITEHITE BED
MDR report key: 3810305
·
Received April 10, 2014
Report
- Report Number
- 1824206-2014-01134
- Event Type
- Malfunction
- Date Received
- April 10, 2014
- Date of Event
- March 13, 2014
- Report Date
- March 13, 2014
- Manufacturer
- HILL-ROM, INC.
- Product Code
- INX
- PMA / PMN Number
- K964223
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECH FOUND THE BRAKE CASTER NOT HOLDING MOST LIKELY DUE TO NORMAL WEAR AND TEAR. THE TECH REPLACED THE BRAKE CASTER TO RESOLVE THE ISSUE. BASED ON THIS INFO, NO FURTHER ACTION IS REQUIRED.
Description of Event or Problem · 1
HILL-ROM RECEIVED A REPORT FROM A HILL-ROM TECH STATING THE HEAD BRAKE CASTER NOT WORKING (BRAKES NOT HOLDING). THE BED WAS LOCATED AT A HILL-ROM SERVICE CENTER NOT IN USE. THERE WAS NO PT/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 |
|---|---|---|---|---|---|---|---|
| 216443 | CLINITRON RITEHITE BED | BED, AIR FLUIDIZED | INX | HILL-ROM, INC. | 0800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |