BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3911262 · Received July 2, 2014

    Report

    Report Number
    3003793491-2014-00313
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 10, 2014
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER REPORTED THAT THE LAST TIME THAT THE DEVICE WAS KNOWN TO FUNCTION NORMALLY WAS ABOUT A MONTH AGO FROM THE REPORTED EVENT. IT IS UNKNOWN IF A DAILY SHIFT CHECK WAS PERFORMED ON THE DATE OF THE EVENT. IT WAS REPORTED THAT THE CUSTOMER FOLLOWS THE AUTOPULSE BATTERY MANAGEMENT PROCEDURE. ZOLL HAS NOT YET RECEIVED THE AUTOPULSE PLATFORM IN COMPLAINT FOR INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE FILED IF AND WHEN THE PRODUCT IS RETURNED AND INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE PLATFORM IN COMPLAINT WAS RETURNED TO ZOLL ON (B)(6) 2014 FOR INVESTIGATION. INVESTIGATION RESULTS AS FOLLOWS: THE REPORTED COMPLAINT WAS CONFIRMED DURING VISUAL INSPECTION. THE LCD DISPLAY WAS NOT FUNCTIONAL. FURTHER INSPECTION IDENTIFIED THAT THE CAUSE WAS THE PROCESSOR PCA BOARD, WHICH WAS NOT FUNCTIONING PROPERLY. ADDITIONAL DAMAGES OBSERVED TO THE PLATFORM INCLUDED A TORN LOAD PLATE COVER. FROM THE CONDITION OF THE PLATFORM, THE TORN LOAD PLATE COVER WAS DUE TO WEAR AND TEAR. DUE TO THE DEFECTIVE PROCESSOR PCA BOARD, A FUNCTIONAL EVALUATION COULD NOT BE PERFORMED AND THE PLATFORM'S ARCHIVE DATA COULD NOT BE DOWNLOADED FOR REVIEW. FOLLOWING REPLACEMENT OF THE BOARD, THE DEVICE PASSED FUNCTIONAL TESTING REQUIREMENTS. BASED ON THE INVESTIGATION, THE PART(S) IDENTIFIED FOR REPLACEMENT WERE THE LOAD PLATE COVER AND PROCESSOR PCA BOARD. IN SUMMARY, THE REPORTED COMPLAINT WAS CONFIRMED DURING VISUAL INSPECTION AND ATTRIBUTED TO A DEFECTIVE PROCESSOR PCA BOARD. FOLLOWING SERVICE, INCLUDING REPLACEMENT OF THIS BOARD, THE DEVICE PASSED ALL TESTING CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TRAINING, THE CONTROL PANEL OF THE AUTOPULSE PLATFORM WENT BLANK. SUBSEQUENTLY, THE ENTIRE DEVICE COULD NOT FUNCTION. THE DEVICE DID NOT DISPLAY ANY MESSAGES BEFORE THE CONTROL PANEL WENT BLANK. IT IS UNKNOWN WHAT WAS TRIED TO FIX THE ISSUE. NO PATIENT INVOLVEMENT WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385896 AUTOPULSE® RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1