FDA Adverse Event
Malfunction
Summary report: N
ADVANCE BED
MDR report key: 3810231
·
Received February 5, 2014
Report
- Report Number
- 1824206-2014-00322
- Event Type
- Malfunction
- Date Received
- February 5, 2014
- Date of Event
- January 9, 2014
- Report Date
- January 9, 2014
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECH FOUND THE HEAD END BRAKE CASTER IS OUT OF ADJUSTMENT. 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 BEDS. THE TECH ADJUSTED THE HEAD END BRAKE CASTER TO RESOLVE THE ISSUE. BASED ON THIS INFO, NO FURTHER ACTION IS REQUIRED.
Description of Event or Problem · 1
THE ACCOUNTS TECH REPORTED THE BRAKES ARE NOT FUNCTIONING. THE BED IS LOCATED IN THE ACCOUNTS BED SHOP. 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 |
|---|---|---|---|---|---|---|---|
| 75875 | ADVANCE BED | A/C POWERED ADJUSTABLE HOSP BED | FNL | HILL-ROM, INC. | 1130 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |