BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIC 50

    MDR report key: 2023837 · Received February 14, 2011

    Report

    Report Number
    3023750-2011-01029
    Event Type
    Malfunction
    Date Received
    February 14, 2011
    Report Date
    January 27, 2011
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS NOT BEEN RECEIVED FOR EVAL AND A F/U REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT THE DEVICE POWERED ON WITHOUT DISPLAY. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY 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