BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® RESUSCITATION SYSTEM MODEL 100

    MDR report key: 3760208 · Received April 18, 2014

    Report

    Report Number
    3003793491-2014-00201
    Event Type
    Malfunction
    Date Received
    April 18, 2014
    Date of Event
    March 27, 2014
    Report Date
    March 27, 2014
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    DRM
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE PLATFORM IN COMPLAINT WAS RETURNED TO ZOLL ON 04/16/2014 FOR INVESTIGATION. INVESTIGATION RESULTS AS FOLLOWS: VISUAL INSPECTION OF THE RETURNED PLATFORM SHOWS THAT THE TOP COVER, ENCODER COVER, BATTERY COMPARTMENT, AND THE PATIENT RESTRAINT BRACKETS WERE DAMAGED. THE PHYSICAL DAMAGES FOUND DURING VISUAL INSPECTION ARE NOT RELATED TO THE REPORTED COMPLAINT THAT THE AUTOPULSE DISPLAYED A COOLING FAN ERROR. THE DAMAGES APPEAR TO HAVE BEEN CAUSED BY NORMAL WEAR AND TEAR (AUTOPULSE MANUFACTURED IN SEPTEMBER OF 2004). A REVIEW OF THE ARCHIVE WAS PERFORMED AND THE REPORTED COMPLAINT OF THE PLATFORM GIVING A COOLING FAN ERROR WHEN POWERED ON WAS NOT CONFIRMED. THE ARCHIVE DATA SHOWS THAT NO SESSIONS OCCURRED ON THE REPORTED EVENT DATE OF (B)(6) 2014. FUNCTIONAL TESTING WAS PERFORMED AND THE REPORTED ISSUE THAT THE PLATFORM WAS GIVING A COOLING FAN ERROR WHEN POWERED ON WAS CONFIRMED. UPON POWERING UP THE PLATFORM, THE ERROR WAS OBSERVED. DURING FUNCTIONAL TESTING, A USER ADVISORY (UA) 11 (MAX PATIENT TEMPERATURE EXCEEDED) MESSAGE WAS ALSO OBSERVED AFTER A FEW COMPRESSIONS. IT WAS FOUND THAT THE TEMPERATURE SENSOR BOARD WAS AT FAULT. BASED ON THE INVESTIGATION, THE PARTS IDENTIFIED FOR REPLACEMENT WERE THE TEMPERATURE SENSOR, TOP COVER, ENCODER COVER, PATIENT RESTRAINT ASSEMBLY AND THE BATTERY COMPARTMENT. IN SUMMARY, THE REPORTED COMPLAINT THAT THE PLATFORM WAS GIVING A COOLING FAN ERROR WHEN POWERED ON WAS CONFIRMED DURING FUNCTIONAL TESTING. THE UA 11 OBSERVED DURING FUNCTIONAL TESTING IS ALSO RELATED TO THE REPORTED COMPLAINT. THE FAULTS WERE FOUND TO BE DUE TO THE DEFECTIVE TEMPERATURE SENSOR BOARD. THE PHYSICAL DAMAGES FOUND DURING VISUAL INSPECTION ARE UNRELATED TO THE REPORTED COMPLAINT. UPON REPLACEMENT OF THE TEMPERATURE SENSOR AND ALL OF THE DAMAGED PARTS, THE PLATFORM PASSED ALL TESTING CRITERIA.

    Additional Manufacturer Narrative · 1

    ZOLL HAS NOT RECEIVED THE PRODUCT IN COMPLAINT. A SUPPLEMENTAL REPORT WILL BE FILED IF AND WHEN THE PRODUCT IS RETURNED AND INVESTIGATION HAS BEEN PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE AUTOPULSE PLATFORM DISPLAYED A COOLING FAN ERROR MESSAGE UPON POWER UP. NO ADVERSE PATIENT SEQUELAE WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237141 AUTOPULSE® RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC MODEL 100

    Patients

    Seq Age Sex Outcome Treatment
    1