FDA Adverse Event
Malfunction
Summary report: N
CENTURY BED
MDR report key: 3810306
·
Received April 10, 2014
Report
- Report Number
- 1824206-2014-01133
- Event Type
- Malfunction
- Date Received
- April 10, 2014
- Date of Event
- March 12, 2014
- Report Date
- March 12, 2014
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE HILL-ROM TECH FOUND THE BRAKE CASTER AND BRAKE STEER CASTER WAS NOT HOLDING IN BRAKE WHEN THE BRAKE PEDAL WAS SET TO THE BRAKE POSITION. THE MOST LIKELY CAUSE IS NORMAL WEAR AND TEAR. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS DID NOT SHOW HILL-ROM PERFORMED ANY PREVENTATIVE MAINTENANCE ON THIS BED. IT IS UNK IF THE FACILITY PERFORMS PREVENTATIVE MAINTENANCE ON THEIR BED. THE TECH ADJUSTED THE BRAKE CASTER AND BRAKE STEER CASTER TO RESOLVE THE ISSUE. BASED ON THIS INFO, NO FURTHER ACTION IS REQUIRED.
Description of Event or Problem · 1
THE ACCOUNT REPORTED THE BED IS NOT BRAKING PROPERLY. THE BED WAS LOCATED ON THE 1ST FLOOR AT THE FACILITY. 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 |
|---|---|---|---|---|---|---|---|
| 216330 | CENTURY BED | A/C POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | 837 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |