BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE? RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3251097 · Received July 29, 2013

    Report

    Report Number
    3003793491-2013-00751
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    June 18, 2013
    Report Date
    July 3, 2013
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE PLATFORM IN COMPLAINT WAS RETURNED TO ZOLL ON (B)(6) 2013 FOR INVESTIGATION. INVESTIGATION RESULTS AS FOLLOWS: VISUAL INSPECTION WAS PERFORMED AND CONFIRMED NO DAMAGES TO THE PLATFORM. A REVIEW OF THE ARCHIVE WAS PERFORMED AS WELL AND NO USER ADVISORY FAULTS WERE NOTED. UPON RECEIPT OF THE PLATFORM, THE MOTOR WAS NOT OPERATING AT ALL AND WAS NOISY. INSPECTION OF THE DEVICE REVEALED THAT A DEFECTIVE MOTOR DRIVETRAIN MAY HAVE LED TO THE ISSUES OBSERVED WITH THE MOTOR. HOWEVER, A DEFINITIVE ROOT CAUSE FOR THE DRIVETRAIN FAILURE COULD NOT BE DETERMINED. IN SUMMARY, THE REPORTED COMPLAINT OF UA 8, UA 45 AND UA 16 WAS NOT CONFIRMED BASED ON REVIEW OF THE ARCHIVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE AUTOPULSE PLATFORM DISPLAYED THE FOLLOWING FAULTS: FAULT 8 - MOTOR CONTROLLER FAULT DETECTED; FAULT 45 - NOT AT "HOME" POSITION AFTER POWER-ON/RESTART; FAULT 16 - TIMEOUT MOVING TO TAKE-UP POSITION. NO ADVERSE PATIENT SEQUELAE WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352361 AUTOPULSE? RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1