BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIC 50

    MDR report key: 1934060 · Received December 2, 2010

    Report

    Report Number
    3023750-2010-01228
    Event Type
    Malfunction
    Date Received
    December 2, 2010
    Report Date
    November 12, 2010
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED AND A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN OUR INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE POWERED ON WITHOUT DISPLAY. 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