BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3803606 · Received May 9, 2014

    Report

    Report Number
    3003793491-2014-00230
    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 OF THE RETURNED PLATFORM SHOWS THAT THE BATTERY LOCK WAS DAMAGED. THE PHYSICAL DAMAGE FOUND DURING VISUAL INSPECTION IS NOT RELATED TO THE REPORTED EVENT OF THE PLATFORM DISPLAYING MULTIPLE ERROR CODES. THE DAMAGE APPEARS TO HAVE BEEN CAUSED BY NORMAL WEAR AND TEAR (AUTOPULSE MANUFACTURED IN JULY OF 2007). A REVIEW OF THE ARCHIVE WAS PERFORMED AND THE REPORTED COMPLAINT OF THE PLATFORM DISPLAYING MULTIPLE ERROR CODES WAS CONFIRMED. THE ARCHIVE DATA SHOWS THAT NO SESSIONS OCCURRED ON THE REPORTED EVENT DATE OF (B)(6) 2014. HOWEVER, THE ARCHIVE SHOWS THAT MULTIPLE USER ADVISORY (UA) 7 (DISCREPANCY BETWEEN LOAD 1 AND LOAD 2 TOO LARGE) MESSAGES AND A UA 2 (COMPRESSION TRACKING ERROR) OCCURRED ON (B)(6) 2014, RATHER THAN ON THE REPORTED EVENT DATE. FUNCTIONAL TESTING WAS PERFORMED AND THE REPORTED ISSUE OF UA7 AND UA2 MESSAGES WAS REPRODUCED. DURING TESTING, THESE USER ADVISORIES WERE OBSERVED. IT WAS FOUND THAT THE LOAD CELL WAS DEFECTIVE. BASED ON THE INVESTIGATION, THE PARTS THAT WERE IDENTIFIED FOR REPLACEMENT ARE THE LOAD CELL AND THE BATTERY LOCK. IN SUMMARY, THE REPORTED COMPLAINT OF MULTIPLE ERROR CODES OCCURRING WAS CONFIRMED BASED ON THE ARCHIVE REVIEW AND DURING FUNCTIONAL TESTING. THE FAULTS WERE FOUND TO BE DUE TO THE DEFECTIVE LOAD CELL. THE PHYSICAL DAMAGE FOUND DURING VISUAL INSPECTION IS UNRELATED TO THE REPORTED COMPLAINT. UPON REPLACEMENT OF THE BATTERY LOCK AND THE LOAD CELL, THE PLATFORM PASSED ALL TESTING CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SHIFT CHECK, THE AUTOPULSE PLATFORM DISPLAYED MULTIPLE ERROR CODES. CUSTOMER DID NOT POWER ON THE PLATFORM TO VERIFY WHICH ERROR CODES WERE DISPLAYED. NO PATIENT INVOLVEMENT WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281947 AUTOPULSE® RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1