BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 2982276 · Received January 25, 2013

    Report

    Report Number
    3003793491-2013-00223
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Date of Event
    December 26, 2012
    Report Date
    December 26, 2012
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORP HAS NOT YET RECEIVED THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED AND WHEN IT IS EVALUATED. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS SUCCESSFULLY RESUSCITATED USING THE AUTOPULSE WITH NO ISSUES. HOWEVER, THE PHYSICIAN AT THE HOSPITAL CONTACTED THE (B)(6) DISPATCH WITH A LIST OF INJURIES HE BELIEVED WERE CAUSED BY THE AUTOPULSE PLATFORM: MULTIPLE BILATERAL RIB FRACTURES, HEMOPNEUMOTHORAX ON RIGHT SIDE, HEMOTHORAX ON LEFT SIDE, FRACTURE OF VERTEBRAE AT T9, INJURY OF AORTIC ARCH, INTIMAL INJURY OF THE DESCENDING AORTA, AND A SMALL CARDIAL EFFUSION. MANUAL CPR WAS DONE BRIEFLY BY A FF/PARAMEDIC BEFORE THE AUTOPULSE WAS APPLIED AND SOME CREPITUS WAS NOTED DURING COMPRESSIONS. PT HAD A HISTORY OF MVA WITH RIB FRACTURES IN (B)(6) AND WAS ON CPAP AT HOME WHEN HE ARRESTED. EMERGENCY CREW ADVISED THE PHYSICIAN THAT THESE INJURIES WERE THE FIRST HEARD OF WITH THE AUTOPULSE AND THAT IN FACT THE EMERGENCY CREW HAS BEEN VERY SUCCESSFUL WITH CARDIAC RESUSCITATION EFFORTS WITH THE AUTOPULSE. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35489 AUTOPULSE RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC. MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1 Other