BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE PLATFORM RESUSCITATION

    MDR report key: 10820859 · Received November 10, 2020

    Report

    Report Number
    3010617000-2020-01163
    Event Type
    Malfunction
    Date Received
    November 10, 2020
    Date of Event
    October 16, 2020
    Report Date
    November 10, 2020
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    DRM
    UDI-DI
    00849111000277
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DURING SERVICE LOANER ON 10/16/2020, THE AUTOPULSE PLATFORM (SERIAL (B)(4)) DISPLAYED FAULT CODE "16" (TIMEOUT MOVING TO TAKE-UP POSITION) ERROR MESSAGE. THE ROOT CAUSE FOR THE REPORTED COMPLAINT WAS DUE TO A DEFECTIVE DRIVETRAIN MOTOR, LIKELY AS A RESULT OF NORMAL WEAR AND TEAR. THE AUTOPULSE PLATFORM WAS MANUFACTURED IN MARCH 2011, AND IT IS 9 YEARS OLD, EXCEEDED ITS EXPECTED SERVICE LIFE OF 5 YEARS. DURING THE VISUAL INSPECTION OF THE RETURNED AUTOPULSE PLATFORM, NO PHYSICAL DAMAGE WAS OBSERVED. FOLLOWING SERVICE, THE AUTOPULSE WAS SUBJECTED TO THE RUN-IN TEST USING THE 95% PATIENT LARGE RESUSCITATION TEST FIXTURE (LRTF) WITH GOOD KNOWN TEST BATTERIES UNTIL DISCHARGED WITHOUT ANY FAULT OR ERROR. THE BRAKE GAP INSPECTION WAS PERFORMED AND VERIFIED THE BRAKE GAP WAS WITHIN THE SPECIFICATION. HISTORICAL COMPLAINTS WERE REVIEWED FOR SERVICE INFORMATION RELATED TO THE REPORTED COMPLAINT, AND THERE WAS NO SIMILAR COMPLAINT REPORTED FOR AUTOPULSE PLATFORM WITH SERIAL NUMBER (B)(4).

    Description of Event or Problem · 1

    DURING SERVICE LOANER ON 10/16/2020, THE AUTOPULSE PLATFORM (SERIAL (B)(4)) DISPLAYED FAULT CODE "16" (TIMEOUT MOVING TO TAKE-UP POSITION) ERROR MESSAGE. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1285628 AUTOPULSE PLATFORM RESUSCITATION CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION MODEL 100 00849111000277

    Patients

    Seq Age Sex Outcome Treatment
    1