BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARROLL HEALTH CARE BEDS

    MDR report key: 892189 · Received October 22, 2004

    Report

    Report Number
    1525712-2004-00108
    Event Type
    Malfunction
    Date Received
    October 22, 2004
    Date of Event
    October 15, 2004
    Report Date
    October 19, 2004
    Manufacturer
    CARROLL HEALTHCARE
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    ISSUE WAS DETECTED ON A BED THAT WAS RETURNED TO, AN INDEPENDENT MANUFACTURER OWNED BY INVACARE CORPORATION. REVERSED WIRE CONDITION IMPACTS AN ELECTRICAL EXTENSION CABLE THAT IS WITHIN THE BED MOTOR CIRCUIT. WITHIN THIS ASSEMBLY THAT IS SUPPLIED BY THE MOTOR MANUFACTURER THE NEUTRAL AND PROTECTIVE EARTH WIRES ARE SWAPPED. GIVEN THIS CONDITION, DEPENDING ON THE QUALITY OF THE NEUTRAL LINE WITHIN THE BRANCH CIRCUIT THE BED IS CONNECTED TO, A SMALL "FLOAT VOLTAGE" OF SEVERAL VOLTS IS POSSIBLE. VOLTAGE IS PRESENT ONLY DURING MOTOR ACTIVATION. ALL MATERIAL IN MANUFACTURER'S STOCK WAS 100% INSPECTED. CAPA HAS BEEN ISSUED TO MOTOR SUPPLIER.

    Description of Event or Problem · 1

    MANUFACTURER BECAME AWARE THAT THE SUPPLIER OF MOTOR EXTENSION CABLES HAD SUPPLIED SOME UNITS WITH THE PROTECTIVE EARTH AND NEUTRAL WIRES SWAPPED. ISSUE WAS IDENTIFIED WHEN A CUSTOMER REPORTED THAT THEY HAD RECEIVED A SHOCK FROM THE BED ACTUATOR. NO INCIDENTS INVOLVING INJURY HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARROLL HEALTH CARE BEDS 880.5100 FNL CARROLL HEALTHCARE BC1180111AE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *