BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUMPER

    MDR report key: 21241272 · Received January 27, 2025

    Report

    Report Number
    1821850-2025-00001
    Event Type
    Malfunction
    Date Received
    January 27, 2025
    Date of Event
    December 3, 2024
    Report Date
    February 20, 2025
    Manufacturer
    MICHIGAN INSTRUMENTS, LLC
    Product Code
    DRM
    PMA / PMN Number
    K972525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ISSUE THAT WAS FOUND WITH THE DEVICE WAS DICUSSED WITH THE USER, AS THE INITIAL USER COMPLAINT COULD NOT BE CONFIRMED. IN SPEAKING WITH THE CUSTOMER IT WAS FOUND THAT THERE IS THE POSSIBILITY THAT THE REGUATOR USED TO RUN THE DEVICE FROM THE GAS SUPPLY MAY NOT HAVE HAD ADEQUATE FLOW, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE COMPLAINT. STRATEGIES TO CHECK FOR AND MAINTAIN ADEQUATE FLOW FROM THE GAS SOURCE WERE DISCUSSED WITH THE USER. DEVICE RETURNED TO USER, AS IT HAD BEEN EVALUATED, TESTED AND ACCEPTED TO FACTORY SPECIFICATIONS.

    Additional Manufacturer Narrative · 0

    SUSPECT DEVICE RETURNED TO MANUFACTURER FOR EVALUATION. UPON EVALUATION, THE USER COMPLAINT THAT THE DEVICE WAS NOT COMPRESSING DEEP ENOUGH WAS NOT CONFIRMED. THE DEVICE HAS BEEN THOROUGHLY EVALUATED AND NO PROBLEMS WERE FOUND. IT WAS ACCEPTED AND TESTED TO FACTORY SPECIFICATIONS. WE ARE ATTEMPTING TO GET ADDITIONAL INFORMATION FROM THE USER, BUT THESE EFFORTS HAVE NOT BEEN SUCCESSFUL THUS FAR. WE WILL UPDATE THIS REPORT IF ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING CARDIAC ARREST THE DEVICE WAS NOT COMPRESSING DEEP ENOUGH. THE DEVICE WAS IMMEDIATELY REMOVED FROM THE PATIENT AND MANUAL COMPRESSIONS WERE RESUMED. THE PATIENT WAS NOT REVIVED. IT IS THE OPERATOR'S OPINION THAT THE PROBLEM WITH THE DEVICE DID NOT CONTRIBUTE TO THE DEATH OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770823 THUMPER EXTERNAL CARDIAC COMPRESSOR DRM MICHIGAN INSTRUMENTS, LLC 1007CC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male