BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIC

    MDR report key: 1381196 · Received March 18, 2009

    Report

    Report Number
    3023750-2009-00062
    Event Type
    Malfunction
    Date Received
    March 18, 2009
    Date of Event
    February 17, 2009
    Report Date
    February 17, 2009
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K012766
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED, BUT ADDITIONAL TIME IS REQUIRED TO COMPLETE THE ANALYSIS. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS A DEFIB COMM ERROR UPON POWERING UP THE DEVICE. NO PATIENT 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