BEUDAMED
    FDA Adverse Event Death Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3042060 · Received March 30, 2013

    Report

    Report Number
    3003793491-2013-00444
    Event Type
    Death
    Date Received
    March 30, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 20, 2013
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS NOT RECEIVED THE PRODUCT FOR EVAL AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PT EVENT AT (B)(6), A (B)(6) WOMAN HAD A SCA ON THE STREET. THE EMS SERVICE STARTED MANUAL COMPRESSIONS AND RUSHED THE PT TO THE HOSPITAL'S ER. IN THE ER ROOM, WHILE CONTINUING TO PERFORM MANUAL COMPRESSION, THE ER TEAM CALLED THE EMS SERVICE FOR AN AUTOPULSE SYSTEM. THE PT WAS CONNECTED TO THE AUTOPULSE. AFTER A FEW COMPRESSIONS THEY HAD TO ADJUST THE LIFEBAND AS IT WAS PLACED TOO LOW ON THE PT. AFTER THE ADJUSTMENT THE AUTOPULSE WAS STARTED AGAIN. AFTER AN UNCLEAR TIME FRAME, SUSTAINED PERFUSING CARDIAC ACTIVITY (ROSC) RESUMED AND THE AUTOPULSE TREATMENT WAS STOPPED. THE AUTOPULSE WAS KEPT AS A STANDBY DURING THE TRANSPORT TO (B)(6) IN (B)(6). ONCE THERE THE PT'S CONDITION WORSENED. AN OPEN HEART SURGERY WAS PERFORMED. DURING THIS PROCEDURE IN THE MYOCARDIUM WAS NOTED. IT IS BELIEVED BY THE CUSTOMER THAT THESE INJURIES WERE CAUSED BY THE AUTOPULSE. ON (B)(6) 2013 ADD'L INFO WAS RECEIVED FROM A MEMBER OF THE TEAM IN PLACE AT THE ER. HE VERBALLY INFORMED ZOLL THAT THE TEAM IN PLACE HAD PERFORMED MANUAL CPR LONGER THAN INITIALLY REPORTED. HE ALSO STATED THAT ONE MEMBER OF THE TEAM IN THE HOSPITAL THAT PERFORMED MANUAL CPR HAS, DURING HIS PRIOR WORK EXPERIENCE, BEEN INSTRUCTED SEVERAL TIMES NOT TO PUSH AN HARD AS HE DOES, AS WELL AS TO ADJUST HIS POSITION ON THE CHEST. ON (B)(6) 2013 RECEIVED ADD'L INFO THAT THE PT WAS TREATED FOR A PULMONARY EMBOLI WITH CPR AND ACTALYSIS. REPORTEDLY, THE PT DIED ON (B)(6) 2013. THE EXACT CAUSE OF DEATH WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131393 AUTOPULSE RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC. 100

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death MANUAL COMPRESSIONS| MANUAL COMPRESSIONS