BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM

    MDR report key: 2132539 · Received June 9, 2011

    Report

    Report Number
    3003793491-2011-00003
    Event Type
    Injury
    Date Received
    June 9, 2011
    Date of Event
    April 15, 2011
    Report Date
    June 8, 2011
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    DRM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE DEVICE (B)(4) INVOLVED IN THE EVENT AND WAS RETURNED TO ZOLL CIRCULATION AND ANALYZED. THE RETURNED AUTOPULSE PLATFORM PERFORMED WITHIN SPECIFICATION WHEN TESTED FOR LOAD CELL CHARACTERIZATION, COMPRESSION DEPTH, AND DUTY CYCLE (CYCLES/MINUTE). BASED ON AVAILABLE CLINICAL PUBLICATION(S), STERNAL FRACTURE IS A POTENTIAL COMPLICATION OF ANY CPR, MANUAL OR MECHANICAL. THE PRIMARY REASONS FOR SUCH FRACTURES DURING CPR INCLUDE ELASTICITY AND ANATOMY OF THE RIB CAGE. THE FRACTURES ARE ALSO INFLUENCED BY ELASTICITY, BONE DENSITY AND ANATOMICAL FEATURES (KYPHOSCOLIOSIS). THE REPORTED COMPLICATION (RIB FRACTURES, HEMOTHORAX) ARE POTENTIAL IMPLICATIONS OF ANY CPR MANUAL OR MECHANICAL AND CONSIDERED TO BE OF RELATIVE SIGNIFICANCE GIVEN THE ALTERNATIVE OF DEATH. (B)(4).

    Description of Event or Problem · 1

    A (B)(6) MALE FOUND ON THE GROUND RECEIVING CPR VIA AUTOPULSE DEVICE WHICH HAD BEEN APPLIED BY ENGINE CREW. PER E-31 CREW, PT WAS FOUND IN ASYSTOLE. NO OBVIOUS EVIDENCE OF TRAUMA NOTED AND WIFE DENIES ANY RECENT HISTORY OF TRAUMA OR ILLNESS. PT DID HAVE AN APPOINTMENT WITH A PHYSICIAN TO HAVE NEWLY DISCOVERED CAROTID STENOSIS EVALUATED. PT WAS ADMINISTERED EPINEPHRINE DURING COMPRESSIONS; ONE MINUTE AFTER ADMINISTRATION, PT WAS FOUND TO HAVE CONVERTED TO VENTRICULAR FIBRILLATION; HE WAS DEFIBRILLATED AT 200J AND CONVERTED BACK TO ASYSTOLE. THIS REPORTED 3 TIMES UNTIL PT DEVELOPED PERSISTENT ASYSTOLE FOR SEVERAL MINUTES THEN CONVERTED TO PEA. THE PEA ALGORITHM WAS CONTINUED UNTIL A COPIOUS AMOUNT OF BLOOD WAS BEING EXPELLED FROM THE KING AIRWAY, HOWEVER, NO BLOOD WAS NOTED IN THE NASOGASTRIC TUBE WHICH WAS IN PLACE VIA THE (B)(4). IT WAS SUSPECTED THAT THE PT MAY HAVE DEVELOPED A HEMOTHORAX AS A RESULT OF THE AUTOPULSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOPULSE RESUSCITATION SYSTEM AUTOPULSE CHEST COMPRESSION DRM ZOLL CIRCULATION 1.5 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other