BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIC

    MDR report key: 1001115 · Received February 14, 2008

    Report

    Report Number
    3023750-2008-00048
    Event Type
    Malfunction
    Date Received
    February 14, 2008
    Date of Event
    January 15, 2008
    Report Date
    January 15, 2008
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K012766
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE DEVICE IS AN AUTOMATIC EXTERNAL DEFIBRILLATOR AND THE ACTUAL DEVICE INVOLVED WAS EVALUATED. FACTORY SERVICE CONFIRMED THE REPORTED ECG COMM ERROR UPON POWERING UP THE UNIT. THEY ISOLATED THE ERROR TO INTERMITTENT CONNECTIONS ON PINS 15 THROUGH 22 ON CONNECTOR J5 ON THE PREAMP BOARD. THEY REPLACED THE CABLE AND CONNECTOR PER SERVICE PROCEDURE TO RESOLVE THE ISSUE. AFTER CABLE REPLACEMENT, THE DEVICE PASSED TESTING AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE UNIT HAD A COMM ERROR. THIS WAS FOUND DURING DEVICE CHECKOUT. THERE WAS NO PT INVOLVEMENT.

    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