BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROPAQ 406

    MDR report key: 1953954 · Received December 16, 2010

    Report

    Report Number
    3023750-2010-00170
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    December 3, 2010
    Report Date
    December 3, 2010
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    DRT
    PMA / PMN Number
    K021681
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE EVAL IS NOT YET COMPLETE. A F/U REPORT WILL BE SUBMITTED WHEN THE EVAL HAS COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY HAD A MICROPAQ THAT BURNED A HOLE IN THE CASE. THE PT DID NOT HAVE A PACEMAKER. NO PT INJURY INVOLVED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROPAQ 406 DRT WELCH ALLYN PROTOCOL, INC. 406

    Patients

    Seq Age Sex Outcome Treatment
    1