FDA Adverse Event
Malfunction
Summary report: N
CLINITRON RITEHITE
MDR report key: 3896781
·
Received May 20, 2014
Report
- Report Number
- 1824206-2014-01547
- Event Type
- Malfunction
- Date Received
- May 20, 2014
- Date of Event
- April 24, 2014
- Report Date
- April 24, 2014
- Manufacturer
- HILL-ROM, INC.
- Product Code
- INX
- PMA / PMN Number
- K964223
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN FOUND THE BRAKES WERE WORN. THIS BED IS A RENTAL UNIT AND IS SUBJECT TO BETWEEN PT INSPECTIONS WHICH INCLUDES THE PM ACTIVITIES. THE TECHNICIAN REPLACED THE BRAKE CASTERS 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 TECHNICIAN STATING THE BRAKES WERE NOT HOLDING. THE BED WAS LOCATED AT THE HILL-ROM SERVICE CENTER. 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 |
|---|---|---|---|---|---|---|---|
| 300014 | CLINITRON RITEHITE | BED, AIR FLUIDIZED | INX | HILL-ROM, INC. | 0800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |