BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSACARE BED

    MDR report key: 3841111 · Received February 26, 2014

    Report

    Report Number
    1824206-2014-00661
    Event Type
    Malfunction
    Date Received
    February 26, 2014
    Date of Event
    January 31, 2014
    Report Date
    January 31, 2014
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HILL-ROM TECHNICIAN FOUND THE COMMUNICATION CABLE HAD NO VISIBLE DAMAGE, BUT WAS NOT WORKING. 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 TECHNICIAN REPLACED THE COMMUNICATION CABLE TO RESOLVE THE ISSUE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    A HILL-ROM TECHNICIAN FOUND THIS BED IN THE BED SHOP WITH A NOTE STATING THE BED EXIT ALARM WAS NOT SENDING AN ALARM TO THE NURSES' STATION. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117715 VERSACARE BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. 3200

    Patients

    Seq Age Sex Outcome Treatment
    1