BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUMPER

    MDR report key: 1163591 · Received September 19, 2008

    Report

    Report Number
    1821850-2008-00004
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    August 4, 2008
    Report Date
    September 3, 2008
    Manufacturer
    MICHIGAN INSTRUMENTS, INC.
    Product Code
    DRM
    PMA / PMN Number
    K851139
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE AND THE INCIDENT THAT OCCURRED WERE INVESTIGATED BY OUR INT'L AFFILIATE WITH ASSISTANCE FROM MICHIGAN INSTRUMENTS. THE DEVICE EVALUATION REVEALED THAT AN INTERNAL CONTROL VALVE (TURBIN VALVE) FAILED WHICH RESULTED IN THE USER BEING UNABLE TO ADJUST THE DEPTH OF COMPRESSION. THE FAILED VALVE WAS RETURNED TO US AND EVALUATED. WE WERE ABLE TO DETERMINE THAT THE VALVE INDICATED EXTENSIVE USE AND A DETENT PIN HAD WORN OUT CAUSING THE FAILURE. THE INCIDENT OCCURED IN A HOSPITAL BUT DESPITE SEVERAL ATTEMPTS WE WER NOT ABLE TO OBTAIN ANY ADDITIONAL INFORMATION ABOUT THE INCIDENT INCLUDING PATIENT INFORMATION OR THE CIRCUMSTANCES OF THE EVENT. WE ARE CONTINUING OUR INVESTIGATION IN TO THIS MATTER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MODEL 1007 THUMPER WAS BEING USED ON A PATIENT IN A HOSPITAL SETTING. AFTER 10 MINUTES OF USE THE COMPRESSION DEPTH COULD NO LONGER BE ADJUSTED WITH THE COMPRESSION DEPTH CONTROL. IT IS NOT KNOWN IF THE PATIENT WAS REVIVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1