BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUMPER

    MDR report key: 8613218 · Received May 15, 2019

    Report

    Report Number
    1821850-2019-00001
    Event Type
    Malfunction
    Date Received
    May 15, 2019
    Date of Event
    April 2, 2019
    Report Date
    May 15, 2019
    Manufacturer
    MICHIGAN INSTRUMENTS, LLC
    Product Code
    DRM
    PMA / PMN Number
    K972525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE WAS EVALUATED BY THE MANUFACTURER AND THE REPORTED CUSTOMER PROBLEM COULD NOT BE CONFIRMED. TWO INDIVIDUAL TEST RUNS OF 25 AND 30 MINUTE DURATIONS, PERFORMED ON SEPARATE DAYS, REVEALED NORMAL AND PROPER OPERATION OF THE DEVICE IN BOTH INSTANCES. DEVICE WAS THOROUGHLY INSPECTED AND RE-TESTED TO FACTORY SPECIFICATIONS. UNIT PASSED ALL FINAL TESTS AND WAS RETURNED TO THE CUSTOMER.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF THE DEVICE, AN EVALUATION WILL BE MADE AND A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    APPROXIMATELY 2 MINUTES AFTER MECHANICAL COMPRESSIONS BEGAN THE DEVICE BEGAN TO SLOW AND EVENTUALLY STOPPED COMPRESSIONS. DEVICE IMMEDIATELY REMOVED FROM PATIENT AND MANUAL COMPRESSIONS RESUMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403976 THUMPER EXTERNAL CARDIAC COMPRESSOR DRM MICHIGAN INSTRUMENTS, LLC 1007CC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR