BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M-4 120V W/PKS

    MDR report key: 2063354 · Received September 23, 2008

    Report

    Report Number
    1022819-2008-00192
    Event Type
    Malfunction
    Date Received
    September 23, 2008
    Date of Event
    July 11, 2008
    Report Date
    July 11, 2008
    Manufacturer
    CHATTANOOGA GROUP
    Product Code
    IRQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED AND IS CURRENTLY UNDER EVAL. THE DEVICE EVAL AND ANY ADD'L FINDINGS WILL BE PROVIDED UPON CONCLUSION OF THE DEVICE EVAL.

    Description of Event or Problem · 1

    THE DEVICE FAILED DURING THE ELECTRICAL CURRENT LEAKAGE TEST. THE DEVICE HAD BEEN RECEIVED BY THE CLINIC AND DELIVERED TO THE BIOMEDICAL DEPT FOR ACCEPTANCE TESTING. THE BIOMEDICAL STAFF REMOVED THE DEVICE FROM THE SHIPPING CRATE. THE STAFF NOTED THAT THE DEVICE AND SHIPPING CONTAINER WAS IN SATISFACTORY CONDITION. THE DEVICE WAS FILLED WITH WATER AND THE TEST DEVICE WAS PLACED IN SERIES WITH THE AC MAINS POWER. AC MAINS POWER WAS APPLIED TO THE DEVICE. AFTER A FEW MOMENTS WITH AC MAINS APPLIED, THE ELECTRICAL CURRENT LEAKAGE TESTER BEGAN TO EMIT FUMES AND SMOKE. THE TECH TERMINATED THE TESTING AND REMOVED AC MAINS FROM THE DEVICE. POST INSPECTION OF THE TEST DEVICE REVEALED THAT IT HAD RECEIVED UNDETERMINED DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M-4 120V W/PKS IRQ CHATTANOOGA GROUP 2502

    Patients

    Seq Age Sex Outcome Treatment
    1