BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1082891 · Received July 18, 2008

    Report

    Report Number
    1082891
    Event Type
    Malfunction
    Date Received
    July 18, 2008
    Date of Event
    July 10, 2008
    Report Date
    July 18, 2008
    Manufacturer
    CHATTANOOGA GROUP
    Product Code
    IRQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US

    Narratives

    Description of Event or Problem · 1

    BRAND NEW UNIT WAS UNDERGOING INITIAL ACCEPTANCE TESTING IN THE BIOMEDICAL DEPARTMENT. THE UNIT WAS VISUALLY INSPECTED AND SHOWED NO SIGNS OF DAMAGE AND WAS IN NEW CONDITION. THE UNIT WAS FILLED WITH WATER AND CONNECTED TO AN ELECTRICAL SAFETY ANALYZER FOR THE INITIAL ELECTRICAL SAFETY TEST. UPON POWERING UP THE UNIT, THE ELECTRICAL SAFETY ANALYZER BEGAN SMOKING AND THE 20 AMP ELECTRICAL BREAKER TRIPPED IN THE ELECTRICAL DISTRIBUTION PANEL. THE MANUFACTURER WAS NOTIFIED AND A REPLACEMENT HYDROCOLLATOR WAS SENT. IT IS OBVIOUS THAT THE UNIT IS MISWIRED AND WAS A SERIOUS SAFETY HAZARD. THE ELECTRICAL SAFETY ANALYZER WAS DESTROYED.====================== MANUFACTURER RESPONSE FOR HOT PACK MACHINE, M4 HYDROCOLLATOR======================TECH SUPPORT NOTIFIED AND A REPLACEMENT UNIT WAS SENT. NO RESPONSE FROM REGULATORY AFFAIRS ON WHETHER OR NOT OUR SAFETY ANALYZER WILL BE REPAIRED/REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * HYDROCOLLATOR IRQ CHATTANOOGA GROUP M-4 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *