BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIC

    MDR report key: 1113325 · Received August 12, 2008

    Report

    Report Number
    3023750-2008-00193
    Event Type
    Malfunction
    Date Received
    August 12, 2008
    Date of Event
    July 21, 2008
    Report Date
    July 24, 2008
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K012766
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE DEVICE IS AN AUTOMATIC EXTERNAL DEFIBRILLATOR AND THE ACTUAL DEVICE INVOLVED WAS EVALUATED. FACTORY SERVICE DUPLICATED THE COMPLAINT THAT WAS CAUSED BY THE AUX INPUT BOARD ASSEMBLY'S CONNECTOR (RESULT CODE) THAT INDICATES WEAR THAT CAUSED A WEAK CONNECTION AND IS THE CAUSE OF THE ARTIFACTS AND INTERMITTENT LEAD FAULT ERROR CODE. ADDITIONALLY, THE INSPECTION ALSO REVEALED THAT AN INDUCTOR (RESULT CODE) ON THE SAME CIRCUIT BOARD WAS DAMAGED CAUSING THE DEVICE TO INCORRECTLY IDENTIFY THE ATTACHED CABLE TYPE AND CAUSING THE 'BEEP' DURING INITIALIZATION. ONCE THE CIRCUIT BOARD WAS REPLACED, THE DEVICE PERFORMS TO SPECIFICATIONS. ONCE REPAIRS WERE COMPLETED, THE DEVICE PASSED TESTING AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER STATED WHEN THEY USED THEIR 12 LEAD CABLE, THE DEVICE WOULD MAKE A LOUD BEEP. THE CUSTOMER TRIED A NEW 12 LEAD CABLE BUT WITH NO HELP; BUT WHEN THEY USED A 5 LEAD CABLE, IT WORKED. NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIC MKJ WELCH ALLYN PROTOCOL, INC. PIC 50

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR