BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® RESUSCITATION SYSTEM MODEL 100

    MDR report key: 4141242 · Received October 3, 2014

    Report

    Report Number
    3010617000-2014-00501
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    August 20, 2014
    Report Date
    September 8, 2014
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL HAS NOT RECEIVED THE PRODUCT IN COMPLAINT. A SUPPLEMENTAL REPORT WILL BE FILED IF AND WHEN THE PRODUCT IS RETURNED AND INVESTIGATION HAS BEEN PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CALL CAME INTO (B)(6) EMERGENCY MEDICAL ON (B)(6) 2014, FOR A (B)(6) MALE PATIENT. MANUAL CPR WAS IN PROGRESS WHEN THE MEDIC ARRIVED. COMPLAINANT ALLEGED THAT THE AUTOPULSE® PLATFORM DISPLAYED A USER ADVISORY (UA) 07 (DISCREPANCY BETWEEN LOAD 1 AND LOAD 2 TOO LARGE) MESSAGE AFTER THE FIRST COMPRESSION. THE MEDIC REPOSITIONED THE PATIENT AND PULLED THE LIFEBAND ALL THE WAY UP, HOWEVER, THE ISSUE DID NOT RESOLVE. THE MEDIC REVERTED BACK TO MANUAL CPR (EXACT LENGTH OF TIME NOT PROVIDED). NO ADVERSE PATIENT SEQUELAE WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619734 AUTOPULSE® RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR MANUAL CPR