BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUMPER

    MDR report key: 380434 · Received February 28, 2002

    Report

    Report Number
    1821850-2002-00002
    Event Type
    Malfunction
    Date Received
    February 28, 2002
    Date of Event
    February 18, 2002
    Report Date
    February 28, 2002
    Manufacturer
    MICHIGAN INSTRUMENTS, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    UNIT WAS APPLIED TO PATIENT TO PROVIDE CPR. AFTER APPROXIMATELY ONE HOUR OF USE, IT WAS REPORTED THAT COMPRESSION BECAME FASTER AND DEEPER. THE UNIT WAS REMOVED FROM THE PATIENT AND MANUAL CPR WAS CONTINUED. CUSTOMER REPORTED THAT A DEATH OR SERIOUS INJURY DID NOT OCCUR DURING THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THUMPER CARDIOPULMONARY RESUSCITATOR DRM MICHIGAN INSTRUMENTS, INC. 1007 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN