BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3803610 · Received May 9, 2014

    Report

    Report Number
    3003793491-2014-00232
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 14, 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 04/22/2014 FOR INVESTIGATION. INVESTIGATION RESULTS AS FOLLOWS: VISUAL INSPECTION WAS PERFORMED AND REVEALED THAT THE SCREW POSTS WERE DAMAGED. NO OTHER VISUAL DAMAGES WERE OBSERVED. FROM THE CONDITION OF THE RETURNED UNIT, THE DAMAGE APPEARS TO BE DUE TO NORMAL WEAR AND TEAR. THE REPORTED USER ADVISORY (UA) 7 FAULT (DISCREPANCY BETWEEN LOAD 1 AND LOAD 2 TOO LARGE) WAS OBSERVED DURING POWER ON OF THE PLATFORM. FURTHER INSPECTION OF THE DEVICE DETERMINED THAT THE CAUSE OF THE UA 7 FAULT WAS A DEFECTIVE LOAD CELL MODULE. NO FAULTS WERE FOUND TO HAVE OCCURRED ON THE REPORTED EVENT DATE OF (B)(6) 2014. THE ARCHIVE DID; HOWEVER, SHOW THE REPORTED UA 7 FAULT OCCURRING ON (B)(6) 2013. BASED ON THE INVESTIGATION, THE PART(S) IDENTIFIED FOR REPLACEMENT WERE THE DAMAGED SCREW POSTS AND THE DEFECTIVE LOAD CELL. IN SUMMARY, THE REPORTED COMPLAINT WAS CONFIRMED DURING ARCHIVE REVIEW AND FUNCTIONAL TESTING. THE UA 7 FAULT WAS ATTRIBUTED TO A DEFECTIVE LOAD CELL MODULE. FOLLOWING REPLACEMENT OF THE DAMAGED PARTS INCLUDING THE DEFECTIVE LOAD CELL, THE DEVICE PASSED ALL TESTING CRITERIA.

    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 UPON POWER UP. THE MESSAGE WAS UNABLE TO BE CLEARED BY POWERING THE DEVICE OFF AND ON. NO PATIENT INVOLVEMENT WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281642 AUTOPULSE® RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1