BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSACARE BED

    MDR report key: 3843756 · Received February 12, 2014

    Report

    Report Number
    1824206-2014-00381
    Event Type
    Malfunction
    Date Received
    February 12, 2014
    Date of Event
    January 15, 2014
    Report Date
    January 15, 2014
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 HILL-ROM USER MANUAL, IF THE BED EXIT ALARM DOES NOT ARM AND ALL THREE MODE INDICATORS ARE FLASHING, REMOVE THE PT AND ZERO THE BED EXIT SYSTEM. A SEARCH OF HILL-ROM MAINTENANCE RECORDS DID NOT SHOW HILL-ROM PERFORMED ANY PREVENTATIVE MAINTENANCE ON THIS BED. IT IS UNK IF THE FACILITY PERFORMS PREVENTATIVE MAINTENANCE ON THEIR BEDS. THREE ATTEMPTS HAVE BEEN MADE TO CONTACT THE ACCOUNT TO OBTAIN THE RESOLUTION FOR THIS ALLEGED ISSUE. BASED ON RECEIVING NO RESPONSE FROM THE ACCOUNT, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    HILL-ROM RECEIVED A REPORT FROM THE ACCOUNT STATING THE PT POSITIONING MODULE WILL NOT SET. THE BED IS LOCATED IN THE SHOP. 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
    92483 VERSACARE BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. 3200

    Patients

    Seq Age Sex Outcome Treatment
    1