BEUDAMED
    FDA Adverse Event Other Summary report: N

    THUMPER

    MDR report key: 207809 · Received January 22, 1999

    Report

    Report Number
    1821850-1999-00002
    Event Type
    Other
    Date Received
    January 22, 1999
    Date of Event
    December 27, 1998
    Report Date
    January 22, 1999
    Manufacturer
    MICHIGAN INSTRUMENTS, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DEVICE WAS BEING USED TO PERFORM CARDIOPULMONARY RESUSCITATION. THE CUSTOMER CLAIMS THE VENTILATOR FAILED. COMPRESSIONS CONTINUED TO WORK FINE, BUT NO OXYGEN IS RELEASED FROM THE VENTILATOR EVEN AT THE MAXIMUM SETTING. WHEN THE UNIT WAS REC'D AT THE MFR, IT WAS APPARENT THAT IT HAD BEEN DAMAGED. IT HAD REC'D A BLOW OF SOME KIND TO THE VENTILATOR CONTROL SUFFICIENT TO BREAK THE KNOB AND DAMAGE THE CASE. DAMAGE TO THE VENTILATOR NEEDLE VALVE IS PREVENTING IT FROM PROVIDING ADEQUATE VENTILATION. PARAMEDICS AT THE SCENE OF THIS EVENT REPORT THAT THE PT WAS DEAD WHEN THEY ARRIVED BUT RESUSCITATION WAS ATTEMPTED USING THE DEVIC FOR CHEST COMPRESSIONS AND A RESUSCITATION BAG FOR VENTILATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *