BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® RESUSCITATION SYSTEM MODEL 100

    MDR report key: 6091589 · Received November 9, 2016

    Report

    Report Number
    3010617000-2016-00800
    Event Type
    Malfunction
    Date Received
    November 9, 2016
    Date of Event
    October 14, 2016
    Report Date
    November 8, 2016
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    DRM
    UDI-DI
    00849111000017
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    EMERGENCY MEDICAL TECHNICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE PLATFORM (S/N: (B)(4)) WAS RETURNED FOR EVALUATION. HISTORICAL COMPLAINTS WERE REVIEWED FOR SERVICE INFORMATION RELATED TO THE REPORTED COMPLAINT AND THERE WAS NO PREVIOUS HISTORY OF RELATED COMPLAINTS FOR AUTOPULSE SN (B)(4). DURING VISUAL INSPECTION, TORN PLATE COVER, CRACKED TOP, MOTOR AND ENCODER COVERS WERE NOTED. AUTOPULSE IS A REUSABLE DEVICE AND WAS MANUFACTURED IN 06/29/2005. THE DAMAGE FOUND IS CHARACTERISTIC OF NORMAL WEAR AND TEAR FOR THE LIFE OF THE DEVICE. REVIEW OF THE ARCHIVE DATA INDICATED, THE AUTOPULSE DISPLAYED SYSTEM ERROR 139 (UNABLE TO HOLD COMPRESSION POSITION) MESSAGE ON THE REPORTED EVENT DATE OF (B)(6) 2016. FUNCTIONAL TESTING COULD NOT BE PERFORMED, THE UNIT PROMPT SYSTEM ERROR 139 (UNABLE TO HOLD COMPRESSION POSITION) WHEN POWERED ON. IN ADDITION, THE MOTOR BRAKE GAP INSPECTION WAS PERFORMED. THE BRAKE GAP WAS TOO WIDE (OUT OF SPECIFICATION). THIS CAUSED THE BRAKE HUB TO MOVE BACKWARD THE AIR GAP, WHICH CAUSED THE BRAKE TO DISENGAGE. IN SUMMARY, THE REPORTED CUSTOMER COMPLAINT WAS CONFIRMED DURING ARCHIVE DATA REVIEW AND FUNCTIONAL TESTING. THE ROOT CAUSE OF THE COMPLAINT WAS DUE TO THE DEFECTIVE BRAKE ASSEMBLY OF DRIVE TRAIN MOTOR.

    Description of Event or Problem · 1

    THE (B)(6) VOL FIRE & RESCUE SQUAD RECEIVED A 911 CALL ON (B)(6) 2016 FOR A (B)(6) YEARS OLD MALE WHO WAS PULSELESS AT THE RESIDENCE HOME. THE CREW PERFORMED MANUAL CPR FOR 2 MINUTES WHILE THEY PREPARE THE AUTOPULSE. THERE WAS NO VISUAL SIGNS OR SYMPTOMS OF TRAUMA. DURING ACTIVE OPERATION, THE AUTOPULSE PERFORMED COMPRESSIONS FOR APPROXIMATELY 35-40 MINUTES THEN DISPLAYED ERROR MESSAGE "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR". THE CREW THEN REVERTED TO MANUAL CPR FOR 1 MINUTE BEFORE REACHING THE EMERGENCY DEPARTMENT. ROSC (RETURN OF SPONTANEOUS CIRCULATION) WAS NEVER ACHIEVED AND THE PATIENT WAS PRONOUNCED DEAD (TIME UNSPECIFIED) AT THE HOSPITAL. PER THE PARAMEDIC, THE CAUSE OF DEATH WAS DUE TO CARDIAC ARREST AND THE PATIENT'S DEATH IS NOT ATTRIBUTED TO THE AUTOPULSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740483 AUTOPULSE® RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC MODEL 100 00849111000017

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR