BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSACARE BED

    MDR report key: 3812540 · Received April 17, 2014

    Report

    Report Number
    1824206-2014-01245
    Event Type
    Malfunction
    Date Received
    April 17, 2014
    Date of Event
    March 22, 2014
    Report Date
    March 22, 2014
    Manufacturer
    HILL-ROM INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HILL-ROM TECHNICIAN FOUND THE BED EXIT ALARM WAS NOT ACTIVATED. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS SHOWED HILL-ROM PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED IN 2013. IT IS UNKNOWN IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. THE HILL-ROM TECHNICIAN ARMED THE BED EXIT TO RESOLVE THE ISSUE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    HILL-ROM RECEIVED A REPORT FROM THE ACCOUNT STATING THE BED EXIT ALARM IS NOT WORKING. THE BED WAS LOCATED AT THE ACCOUNT IN MEDSURG ROOM 9108. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAIN (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235998 VERSACARE BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM INC. 3200

    Patients

    Seq Age Sex Outcome Treatment
    1