BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIC 50

    MDR report key: 2030292 · Received March 21, 2011

    Report

    Report Number
    3023750-2011-01044
    Event Type
    Malfunction
    Date Received
    March 21, 2011
    Report Date
    March 1, 2011
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RECEIVED AND A F/U REPORT WILL BE PROVIDED WHEN OUR INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE DISPLAYED HEAVY ARTIFACT VIA THE 12 LEAD CABLE THAT PREVENTED THE DEVICE FROM OBTAINING AN ECG SIGNAL. COMPLAINANT INDICATED THAT THERE WAS NO PT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIC 50 AUTOMATED EXTERNAL DEFIB MKJ WELCH ALLYN PROTOCOL, INC. PIC50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA