BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 2836977 · Received October 11, 2012

    Report

    Report Number
    3003793491-2012-00059
    Event Type
    Malfunction
    Date Received
    October 11, 2012
    Date of Event
    September 11, 2012
    Report Date
    September 11, 2012
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE DEVICE (S/N (B)(4)) INVOLVED IN THE EVENT WAS RETURNED TO ZOLL CIRCULATION ON (B)(4) 2012 AND WAS ANALYZED. THE REPORTED PROBLEM WAS CONFIRMED. BATTERY CONNECTOR AND LOCK WERE DAMAGED. THE ARCHIVE DATA INDICATED NUMEROUS USER ADVISORY MESSAGES; "UA45" (DRIVE SHAFT NOT AT HOME POSITION), "UA18" (NO LOAD CHANGE WAS DETECTED AT THE LOAD PLATE. SUSPECT NO PATIENT PRESENT OR PATIENT TOO SMALL), "UA3" (ERROR COMMUNICATING WITH BATTERY CONTROLLER). ARCHIVE DATA ALSO SHOWS THAT A SMALL PATIENT/OBJECT WAS USED ON BOARD DURING COMPRESSIONS. NO ADVERSE EVENT WAS REPORTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE AUTOPULSE UNIT WILL NOT POWER ON. THE BATTERY LOCK IS BENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other