BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSACARE BED

    MDR report key: 3844818 · Received March 12, 2014

    Report

    Report Number
    1824206-2014-00829
    Event Type
    Malfunction
    Date Received
    March 12, 2014
    Date of Event
    February 13, 2014
    Report Date
    February 13, 2014
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HILL-ROM TECHNICAL SUPPORT REPRESENTATIVE SUGGESTED REPLACING THE EXTERNAL BUZZER AND THE ACCOUNT ORDERED AND RECEIVED THE BUZZER. PER THE HILL-ROM USER MANUAL, WARNING: THE BED EXIT ALARM SYSTEM IS NOT INTENDED AS A SUBSTITUTE FOR GOOD NURSING PRACTICES. THE BED EXIT ALARM SYSTEM MUST BE USED IN CONJUNCTION WITH A SOUND RISK ASSESSMENT AND PROTOCOL. PER THE HILL-ROM USER MANUAL, IF THE BED EXIT ALARM DOES NOT ARM AND ALL THREE MODE INDICATORS ARE FLASHING, REMOVE THE PATIENT AND ZERO THE BED EXIT SYSTEM. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS DID NOT SHOW HILL-ROM PERFORMED ANY PREVENTATIVE MAINTENANCE ON THIS BED. IT IS UNKNOWN IF THE FACILITY PERFORMS PREVENTATIVE MAINTENANCE ON THEIR BEDS. THE HILL-ROM TECHNICAL SUPPORT REPRESENTATIVE CONTACTED THE ACCOUNT TWO ADDITIONAL TIMES TRYING TO DETERMINE IF THE ACCOUNT HAS REPLACED THE EXTERNAL BUZZER AND IF THAT RESOLVED THE ISSUE. THERE HAS BEEN NO REPLY RECEIVED FORM THE ACCOUNT. THEREFORE, NO FURTHER INFORMATION IS AVAILABLE ON THE REPAIR OF THE BED AT THIS TIME. IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED, THE ADDITIONAL RELEVANT INFORMATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    HILL-ROM TECHNICAL SUPPORT RECEIVED A REPORT FROM THE ACCOUNT STATING THE BED EXIT ALARM WAS NOT LOUD ENOUGH (BARELY AUDIBLE WITH VOLUME TURNED TO HIGH). THE BED WAS LOCATED IN THE BED SHOP AT THE ACCOUNT. THERE WAS NO PATIENT/USER INJURY REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149328 VERSACARE BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. 3200

    Patients

    Seq Age Sex Outcome Treatment
    1