BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3822117 · Received May 20, 2014

    Report

    Report Number
    3003793491-2014-00254
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    March 21, 2014
    Report Date
    May 14, 2014
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER ALSO REPORTED THAT WHEN THE AUTOPULSE PLATFORM WAS BROUGHT TO THE STATION, IT WORKED FINE, HOWEVER SOME PIXILATION WAS OBSERVED. THE AUTOPULSE PLATFORM (S/N (B)(4)) WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. VISUAL INSPECTION OF THE RETURNED PLATFORM SHOWS THAT THE FRONT ENCLOSURE WAS DAMAGED. THE PHYSICAL DAMAGE FOUND DURING VISUAL INSPECTION IS NOT RELATED TO THE REPORTED EVENT. THE DAMAGE APPEARS TO HAVE BEEN CAUSED BY NORMAL WEAR AND TEAR (AUTOPULSE MANUFACTURED IN 10/2007). A REVIEW OF THE ARCHIVE WAS PERFORMED AND IT SHOWS THAT MULTIPLE USER ADVISORY 45 (NOT AT "HOME" POSITION AFTER POWER-ON/RESTART) MESSAGES OCCURRED ON THE REPORTED EVENT DATE OF (B)(6) 2014. HOWEVER, THE OBSERVED UA45 IS NOT RELATED TO THE REPORTED COMPLAINT. FUNCTIONAL TESTING WAS PERFORMED AND THE REPORTED ISSUE COULD NOT BE REPRODUCED. THE LCD AND THE PROCESSOR BOARD WERE INSPECTED AND NO PROBLEMS WERE OBSERVED. TESTING OF THE PLATFORM COULD NOT DUPLICATE THE PROBLEM CONDITION. ADDITIONAL TESTING OF THE PLATFORM FOUND THAT ONE OF THE LOAD CELLS WAS BAD. BASED ON THE INVESTIGATION, THE PARTS IDENTIFIED FOR REPLACEMENT WERE THE LOAD CELL AND THE FRONT ENCLOSURE. IN SUMMARY, THE REPORTED COMPLAINT WAS NOT CONFIRMED DURING FUNCTIONAL TESTING. THE PHYSICAL DAMAGE FOUND DURING VISUAL INSPECTION IS UNRELATED TO THE REPORTED COMPLAINT. THE OBSERVED UA45 DURING THE ARCHIVE REVIEW IS UNRELATED TO THE REPORTED COMPLAINT. THE ROOT CAUSE FOR UA45 WAS UNABLE TO BE DETERMINED. HOWEVER, PER THE AUTOPULSE® RESUSCITATION SYSTEM MODEL 100 USER GUIDE (PN: 12555-001), IF THE DRIVESHAFT IS NOT AT ITS HOME POSITION WHEN THE AUTOPULSE IS POWERED ON, A USER ADVISORY (45) WILL OCCUR. THE OBSERVED DEFECTIVE LOAD CELL DURING FUNCTIONAL TESTING IS ALSO UNRELATED TO THE REPORTED COMPLAINT. UPON REPLACEMENT OF THE LOAD CELL AND THE FRONT ENCLOSURE, THE PLATFORM PASSED ALL TESTING CRITERIA.

    Description of Event or Problem · 1

    COMPLAINANT REPORTED THAT THE LCD SCREEN ON THE AUTOPULSE® PLATFORM WAS COMPLETELY PIXILATED WHEN TURNED ON. AFTER THE DEVICE WAS TURNED ON/OFF A FEW TIMES, IT WAS ABLE TO FUNCTION PROPERLY. THERE WERE NO REPORTS OF ANY PATIENT INVOLVEMENT AND NO OTHER PROBLEMS WERE REPORTED. MANUFACTURER DETERMINED THAT THIS EVENT WAS NOT A REPORTABLE MALFUNCTION AS IT WAS NOT CONSIDERED TO BE A SAFETY HAZARD AND THERE WERE NO REPORTS OF PATIENT/USER SAFETY ISSUES. THE AUTOPULSE® PLATFORM WAS SUBSEQUENTLY RETURNED TO THE MANUFACTURER FOR INVESTIGATION. UPON REVIEW OF THE ARCHIVE DATA, IT WAS OBSERVED THAT MULTIPLE USER ADVISORY (UA) 45 (NOT AT "HOME" POSITION AFTER POWER-ON/RESTART) MESSAGES OCCURRED ON THE REPORTED EVENT DATE OF (B)(6) 2014. ALTHOUGH THE CUSTOMER DID NOT REPORT THE UA, THIS IS CONSIDERED TO BE A REPORTABLE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299532 AUTOPULSE® RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1