FDA Adverse Event
Malfunction
Summary report: N
VERSACARE BED
MDR report key: 4003126
·
Received June 26, 2014
Report
- Report Number
- 1824206-2014-01844
- Event Type
- Malfunction
- Date Received
- June 26, 2014
- Date of Event
- May 28, 2014
- Report Date
- May 28, 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 TECH FOUND THE COMMUNICATION CABLE WAS PINCHED. MOST LIKELY CAUSE WAS THE CABLE NOT BEING PROPERLY STOWED BEFORE THE BED WAS TRANSPORTED. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS SHOWED HILL-ROM PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED IN 2013 THROUGH 2014. IT IS UNK IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. THE TECH REPLACED THE COMMUNICATION CABLE TO RESOLVE THE ISSUE. BASED ON THIS INFO, NO FURTHER ACTION IS REQUIRED.
Description of Event or Problem · 1
THE ACCOUNT REPORTED THE BED HAS NO NURSE CALL FUNCTION. THE BED WAS LOCATED 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 |
|---|---|---|---|---|---|---|---|
| 373234 | VERSACARE BED | A/C POWERED ADJUSTABLE HOSP BED | FNL | HILL-ROM, INC. | 3200 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |