BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3914103 · Received July 3, 2014

    Report

    Report Number
    3003793491-2014-00316
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 6, 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
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE PLATFORM IN COMPLAINT WAS RETURNED TO ZOLL ON (B)(4) 2014 FOR INVESTIGATION. INVESTIGATION RESULTS AS FOLLOWS: VISUAL INSPECTION WAS PERFORMED AND NO EXTERNAL DAMAGES WERE OBSERVED. THE REPORTED COMPLAINT OF A USER ADVISORY 7 MESSAGE (DISCREPANCY BETWEEN LOAD 1 AND LOAD 2 TOO LARGE) WAS OBSERVED DURING POWER ON OF THE PLATFORM. FURTHER INSPECTION DETERMINED THE CAUSE TO BE A DEFECTIVE LOAD CELL. DURING INSPECTION OF THE PLATFORM, THE REPORTED COMPLAINT OF A STICKY CLUTCH WAS ALSO CONFIRMED. NO OTHER ISSUES WERE IDENTIFIED DURING FUNCTIONAL TESTING. A REVIEW OF THE ARCHIVE WAS PERFORMED AND MULTIPLE UA 7 MESSAGES WERE OBSERVED, INCLUDING ON THE REPORTED EVENT DATE OF (B)(4) 2014. BASED ON THE INVESTIGATION, THE PART(S) IDENTIFIED FOR REPLACEMENT WERE THE SINGLE POINT LOAD CELL AND CLUTCH PLATE. IN SUMMARY, THE REPORTED COMPLAINT OF A UA 7 FAULT WAS CONFIRMED DURING ARCHIVE REVIEW AS WELL AS FUNCTIONAL TESTING. THE UA 7 FAULT WAS FOUND TO BE DUE TO A FAILED LOAD CELL. THE REPORTED COMPLAINT OF THE STICKY CLUTCH PLATE WAS ALSO CONFIRMED DURING INSPECTION OF THE PLATFORM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SHIFT CHECK, THE AUTOPULSE PLATFORM DISPLAYED A USER ADVISORY (UA) 7 (DISCREPANCY BETWEEN LOAD 1 AND LOAD 2 TOO LARGE) MESSAGE THAT COULD NOT BE CLEARED. THE CLUTCH WAS ALSO FOUND TO BE STICKY. NO PATIENT INVOLVEMENT WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391405 AUTOPULSE® RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1