BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUMPER

    MDR report key: 846787 · Received March 9, 2007

    Report

    Report Number
    1821850-2007-00002
    Event Type
    Malfunction
    Date Received
    March 9, 2007
    Date of Event
    August 17, 2006
    Report Date
    March 7, 2007
    Manufacturer
    MICHIGAN INSTRUMENTS, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNET E- MAIL COMMUNICATION DIFFICULTIES WITH THE KOREAN REP (KCP MEDICAL PRODUCTS) PREVENTED NORMAL REPORTING AND REPAIR PROCESSES. FACTORY WAS INITIALLY CONTACTED WITH DEVICE SERVICE REQUEST ON 12/22/06. FACTORY WAS INFORMED OF DEVICE FAILING WHILE IN USE ON PT ON 02/26/07. FACTORY RECEIVED ADDITIONAL PT INFORMATION ON 03/05/07. ROOT CAUSE WAS MODIFICATION BY CUSTOMER TO THE DEVICE VIA A CHECK O2 INLET CONNECTOR THAT PREVENTED PROPER VENTING OF THE DEVICE UPON SHUTDOWN WHICH DID NOT ALLOW INTERNAL COMPONENTS TO RETURN TO A SAFE STARTING "HOME" POSITION. ORIGINAL CONFIGURATION O2 INLET CONNECTOR INSTALLED AND CUSTOMER INFORMED VIA FOLLOW-UP LETTER. ALSO PROVIDED TO CUSTOMER RELATED RECALL INFORMATION FOR C/RRN 1821850-08/04/06-001-C PERTAINING TO PROPER SHUT DOWN PROCEDURE.

    Description of Event or Problem · 1

    AS REPORTED, THE DEVICE WAS NOT WORKING. VAGUE REPORTING RECEIVED FROM CONTACT.

    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 YR