BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIC 50

    MDR report key: 1870265 · Received October 6, 2010

    Report

    Report Number
    3023750-2010-01200
    Event Type
    Malfunction
    Date Received
    October 6, 2010
    Report Date
    September 15, 2010
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RECEIVED AND A FOLLOW-UP 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'S DISPLAY WAS DISTORTED AND NO CLINICAL INFORMATION COULD BE SEEN. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT 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. PC50 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA