FDA Adverse Event
Malfunction
Summary report: N
CLINITRON RITEHITE BED
MDR report key: 3932199
·
Received April 3, 2014
Report
- Report Number
- 1824206-2014-01083
- Event Type
- Malfunction
- Date Received
- April 3, 2014
- Date of Event
- March 6, 2014
- Report Date
- March 6, 2014
- Manufacturer
- HILL-ROM, INC.
- Product Code
- INX
- PMA / PMN Number
- K964223
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE HILL-ROM TECH FOUND THE PT FOOT LEFT CASTER NOT HOLDING. THE TECH REPLACED THE LEFT FOOT 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 HILL-ROM TECH STATING THE FOOT LEFT BRAKE CASTER WAS NOT HOLDING. THE BED WAS LOCATED AT THE ACCOUNT. THERE WAS NO PT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 200261 | CLINITRON RITEHITE BED | BED, AIR FLUIDIZED | INX | HILL-ROM, INC. | 0800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |