BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSACARE BED

    MDR report key: 3842627 · Received February 24, 2014

    Report

    Report Number
    1824206-2014-00581
    Event Type
    Malfunction
    Date Received
    February 24, 2014
    Date of Event
    January 27, 2014
    Report Date
    January 27, 2014
    Manufacturer
    HILL-ROM, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN FOUND A DAMAGED COMMUNICATION CABLE. DURING USAGE THE PINS FROM THE PORT CONNECTED TO THE FACILITY WALL SIDE MAY BECOME DAMAGED (BROKEN, BENT, ETC). THE PRIMARY ROOT CAUSE FOR THIS IS THAT THE COMMUNICATION CABLE IS NOT PROPERLY REMOVED FROM THE WALL AND SECURED TO THE BED FRAME BEFORE TRANSPORTING THE BED. WHEN THE COMMUNICATION CABLE IS PULLED FROM THE WALL AT AN ANGLE THERE IS A POTENTIAL FOR THE PINS/CONNECTOR TO GET DAMAGED. THIS IS AN INHERENT PRODUCT USE CASE ISSUE (POTENTIAL MISUSE) AND NOT A PRODUCT FAILURE TO MEET THE SPECIFIED PERFORMANCE REQUIREMENTS. NURSE CALL SYSTEMS IN ACCORDANCE WITH UL 1069 REQUIRES THAT THE NURSE CALL FUNCTION BE SUPERVISED, MEANING THAT IF FOR ANY REASON THE CIRCUIT IS INTERRUPTED A NURSE CALL OR TROUBLE SIGNAL IS SENT TO THE NURSE'S STATION. WHAT THIS MEANS IT THAT THERE IS NO WAY FOR A SIDECOM COMMUNICATION CABLE TO HAVE A BENT PIN, BROKEN WIRE OR OTHER ISSUE INT HE NURSE CALL CIRCUIT WITHOUT THE FACILITY STAFF HAVING KNOWLEDGE WITHOUT PRIOR CANCELLATION OF A NURSE CALL. THE TECHNICIAN REPLACED THE COMMUNICATION CABLE TO RESOLVE THE ISSUE. BASED ON THIS INFO, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE ACCOUNT REPORTED THE BED HAS NO NURSE CALL FUNCTION. 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
    111995 VERSACARE BED A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM, INC. 3200

    Patients

    Seq Age Sex Outcome Treatment
    1