BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIC

    MDR report key: 2240616 · Received September 24, 2007

    Report

    Report Number
    3023750-2007-00254
    Event Type
    Malfunction
    Date Received
    September 24, 2007
    Date of Event
    September 4, 2007
    Report Date
    September 6, 2007
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K012766
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS AN AUTOMATIC EXTERNAL DEFIBRILLATOR AND THE ACTUAL DEVICE INVOLVED WAS EVALUATED. INVESTIGATION CONFIRMED THE REPORTED PROBLEM. TROUBLE-SHOOTING ISOLATED THE CAUSE OF THE MALFUNCTION TO A DEFECTIVE ECG CABLE AND CONNECTOR. THE CABLE AND CONNECTOR WERE REPLACED TO RESTORE DEVICE OPERATION. THE REPAIRED DEVICE WAS RETURNED TO THE CUSTOMER AFTER PASSING ACCEPTANCE TESTING. ADDITIONAL INFORMATION: (B)(6) 2007 2:30 PM; AGE AT TIME OF EVENT: (B)(6); MALE; (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THIS UNIT IS DISPLAYING "SHOCK ADVISED" WHEN THE UNIT IS HOOKED UP TO NIBP ONLY EVEN THOUGH THERE WAS NO ECG OR DEFIB PADS HOOKED UP TO 2 DIFFERENT PATIENTS. SCREEN ALSO SHOWED MAY VERTICAL LINES. ALSO, WHEN UNIT WAS BACK AT THE OFFICE IT SHOWED A HEART RATE OF 249 W/O A PT OR SIMULATOR, ETC. HOOKED UP TO IT. NO HARM TO EITHER PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIC MKJ WELCH ALLYN PROTOCOL, INC. PIC50

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR