BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFE-STAT MODEL 1008

    MDR report key: 4912242 · Received July 14, 2015

    Report

    Report Number
    1821850-2015-00005
    Event Type
    Malfunction
    Date Received
    July 14, 2015
    Date of Event
    June 18, 2015
    Report Date
    July 14, 2015
    Manufacturer
    MICHIGAN INSTRUMENTS, INC
    Product Code
    DRM
    PMA / PMN Number
    K073079
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING PHONE CONVERSATIONS WITH THE LOGISTICS MANAGER/USERS IT WAS APPARENT THAT THE REPORTED PROBLEM WAS CAUSED BY A FAILED OR IMPROPERLY INSTALLED LIP VALVE IN THE PATIENT DEMAND VALVE. THIS WAS DETERMINED BASED ON THE REPORTED OBSERVATIONS DURING AND FOLLOWING THE EVENT. A REPLACEMENT LIP VALVE WAS SENT AND INSTALLED BY THE USER. THE DEVICE IS NOW WORKING PROPERLY.

    Description of Event or Problem · 1

    ON AN EMERGENCY CALL A PATIENT WAS FOUND IN CARDIAC ARREST AND THE UNIT WAS APPLIED TO PROVIDE CARDIOPULMONARY RESUSCITATION. IT WAS REPORTED THAT UPON INITIATION OF THE RESUSCITATION ATTEMPT PROPER CHEST COMPRESSIONS WERE PERFORMED BUT A LACK OF ADEQUATE CHEST RISE WAS NOTICED. VENTILATION VOLUME WAS INCREASED BUT THERE WAS NO CHANGE IN CHEST RISE. AT THAT POINT, THE VENTILATION HOSE WAS REMOVED AND MANUAL VENTILATION CONTINUED. .THE PATIENT WAS NOT REVIVED. SUBSEQUENT TESTS DETERMINED THAT THE UNIT WAS NOT PROVIDING PROPER VENTILATION. THE PARAMEDIC AT THE SCENE STATED THAT THE FAILURE OF THE EQUIPMENT DID NOT CONTRIBUTE TO THE OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458201 LIFE-STAT MODEL 1008 EXTERNAL CARDIAC COMPRESSOR DRM MICHIGAN INSTRUMENTS, INC 1008 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR