BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFE-STAT

    MDR report key: 2455827 · Received January 30, 2012

    Report

    Report Number
    1821850-2012-00001
    Event Type
    Malfunction
    Date Received
    January 30, 2012
    Date of Event
    January 4, 2012
    Report Date
    January 31, 2012
    Manufacturer
    MICHIGAN INSTRUMENTS, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A THOROUGH INVESTIGATION WAS INITIATED AND COMPLETED ON THIS UNIT. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. THROUGHOUT EXTENSIVE TESTING COMPRESSION DEPTH REMAINED CONSISTENT AND WITHIN REQUIRED SPECIFICATIONS. HOWEVER, THE DEVICE WOULD NOT COMPRESS BEYOND 6CM DUE TO A DAMAGED CDNV (COMPRESSION DEPTH NEEDLE VALVE). THE UNIT WAS RECEIVED DIRTY AND OBVIOUSLY IN NEED OF STANDARD PREVENTIVE MAINTENANCE. CYCLE COUNT WAS FOUND TO BE VERY NEAR 1,000,000 AT WHICH TIME FACTORY SERVICE IS RECOMMENDED. THE CDNV WAS REPAIRED, RECOMMENDED FACTORY SERVICE PERFORMED, AND THE UNIT RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE DEVICE WAS APPLIED TO A PATIENT IN CARDIAC ARREST. IT WAS REPORTED THAT AFTER SEVERAL MINUTES, COMPRESSIONS DEPTH INCREASED TO 8CM. THE PATIENT DID NOT SURVIVE, ALTHOUGH, THE REPORTER STATED THAT THE DEVICE PROBLEM DID NOT CONTRIBUTE TO THE DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFE-STAT CARDIOPULMONARY RESUSCITATOR DRM MICHIGAN INSTRUMENTS, INC. 1008

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR