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