BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3165650 · Received June 3, 2013

    Report

    Report Number
    3003793491-2013-00662
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 13, 2013
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE RESUSCITATION SYSTEM MODEL (SN (B)(4)) WAS RETURNED TO THE DISTRIBUTOR FOR INVESTIGATION. CUSTOMER'S REPORTED ISSUE COULD NOT BE CONFIRMED. THE LCD SCREEN WAS REPLACED AND THE PLATFORM PASSED FINAL TESTING. BASED ON THE EVALUATION RESULTS, A DEFINITIVE ROOT CAUSE FOR THE CUSTOMER'S REPORTED ISSUE COULD NOT BE DETERMINED. PMA: STN NUMBER K112998.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO ZOLL DISTRIBUTOR THAT THE SCREEN ON THE AUTOPULSE PLATFORM COULD NOT SHOW ANYTHING. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2013: THIS EVENT OCCURRED DURING PREPARATION FOR USE OR DAILY SHIFT CHECK. ACCORDING TO THE ARCHIVE FILE, ERRORS HAD NO APPEARED ON THE SCREEN PRIOR TO THIS EVENT. NO PATIENT INVOLVEMENT WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243721 AUTOPULSE RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC. 100

    Patients

    Seq Age Sex Outcome Treatment
    1