BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® RESUSCITATION SYSTEM MODEL 100

    MDR report key: 6097759 · Received November 11, 2016

    Report

    Report Number
    3010617000-2016-00811
    Event Type
    Malfunction
    Date Received
    November 11, 2016
    Date of Event
    October 18, 2016
    Report Date
    November 10, 2016
    Manufacturer
    ZOLL CIRCULATION, INC
    Product Code
    DRM
    UDI-DI
    00849111000512
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE AUTOPULSE PLATFORM (S/N: (B)(4) WAS RETURNED FOR EVALUATION. HISTORICAL COMPLAINTS WERE REVIEWED FOR SERVICE INFORMATION RELATED TO THE REPORTED COMPLAINT AND THERE WAS NO PREVIOUS HISTORY OF RELATED COMPLAINTS FOR AUTOPULSE SN (B)(4). DURING VISUAL INSPECTION, IT WAS NOTED THAT ONE OF THE TOP COVER WIRE STAND WAS CUT. DURING ARCHIVE DATE REVIEW, NO CRITICAL ISSUE WAS FOUND. CUSTOMER REPORTED COMPLAINT OF ERROR MESSAGE UA 07 (BETWEEN LOAD 1 AND LOAD 2 TOO LARGE) WAS NOT CONFIRMED ON THE DATE OF THE EVENT. THE AUTOPULSE PASSED FUNCTIONAL TESTING WITH NO FAULT OR ERRORS. IN ADDITION, A RUN-IN TEST WAS PERFORMED USING 95% PATIENT LARGE RESUSCITATION TEST FIXTURE (LRTF) WITH KNOWN GOOD TEST BATTERIES UNTIL DISCHARGED WITHOUT ANY FAULT OR ERROR. THE LOAD CELL CHARACTERIZATION TEST CONFIRMED BOTH LOAD CELL MODULES ARE FUNCTIONING WITHIN THE SPECIFICATION. IN SUMMARY, THE REPORTED CUSTOMER COMPLAINT WAS NOT CONFIRMED DURING ARCHIVE DATA REVIEW AND FUNCTIONAL TESTING. THERE WERE NO DEVICE DEFICIENCIES FOUND DURING EVALUATION OF THE RETURNED PLATFORM THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT. THE ROOT CAUSE OF THE COMPLAINT COULD NOT BE DETERMINED. THE AUTOPULSE HAS PASSED ALL THE TESTING AND MEETS ALL REQUIRED SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SHIFT CHECK, THE AUTOPULSE PLATFORM (SN: (B)(4) WOULD NOT FUNCTION AND WAS DISPLAYING "UA07 (DISCREPANCY BETWEEN LOAD 1 AND LOAD 2 TOO LARGE)" ERROR MESSAGE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746400 AUTOPULSE® RESUSCITATION SYSTEM MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION, INC MODEL 100 00849111000512

    Patients

    Seq Age Sex Outcome Treatment
    1