BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCE BED

    MDR report key: 3810328 · Received April 10, 2014

    Report

    Report Number
    1824206-2014-01144
    Event Type
    Malfunction
    Date Received
    April 10, 2014
    Date of Event
    March 13, 2014
    Report Date
    March 13, 2014
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HILL-ROM TECHNICIAN THE BED EXIT NOT WORKING DUE TO THE BED EXIT STRIPS BEING INOPERATIVE. PER THE HILL-ROM SERVICE MANUAL THE ADVANCE SERIES BED REQUIRES EFFECTIVE MAINTENANCE PROGRAM. PREVENTATIVE MAINTENANCE WILL MINIMIZE DOWNTIME DUE TO EXCESSIVE WEAR. ENSURE THE BED EXIT SYSTEM WORKS PROPERLY AND THAT IT PLACES THE APPROPRIATE CALL WHEN ACTIVATED. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS SHOWED HILL-ROM PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED IN 2006-2013. IT IS UNKNOWN IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. THE TECHNICIAN REPLACED BED EXIT STRIPS TO RESOLVE THE ISSUE. THE TECHNICIAN THOROUGHLY TESTED THE BED EXIT SYSTEM AND IT FUNCTIONED AS DESIGNED. BASED ON THIS INFO, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    HILL-ROM REC'D A REPORT FROM THE ACCOUNT STATING THE BED EXIT WOULD NOT ALARM. THE BED WAS LOCATED AT THE ACCOUNT IN ROOM 245. 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
    216533 ADVANCE BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. 1105

    Patients

    Seq Age Sex Outcome Treatment
    1