BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPULSE® RESUSCITATION MODEL 100

    MDR report key: 7104705 · Received December 11, 2017

    Report

    Report Number
    3010617000-2017-01135
    Event Type
    Malfunction
    Date Received
    December 11, 2017
    Date of Event
    November 14, 2017
    Report Date
    December 11, 2017
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    DRM
    UDI-DI
    00849111000772
    PMA / PMN Number
    K112998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE RETURNED AUTOPULSE PLATFORM (SN (B)(4)) CONFIRMED THE CUSTOMER COMPLAINT OF A LCD BACK LIGHT NOT WORKING. LCD SCREEN WAS REPLACED TO REMEDY THE ISSUE. ADDITIONALLY, IT WAS NOTED THAT ONE GRIP STRIP IS MISSING AND ONE GRIP STRIP IS DAMAGED. THE AUTOPULSE PLATFORM IS A REUSABLE DEVICE AND WAS MANUFACTURED ON 2009. THE COMBINATION OF ISSUES FOUND DURING VISUAL INSPECTION IS CHARACTERISTIC OF NORMAL WEAR AND TEAR FOR THE LIFE OF THE DEVICE. THE PLATFORM HAS EXCEEDED ITS EXPECTED SERVICE LIFE OF 5 YEARS. AFTER PARTS REPLACEMENT, THE DEVICE WAS FURTHER TESTED TO FULL SPECIFICATION. HISTORICAL COMPLAINTS WERE REVIEWED FOR SERVICE INFORMATION RELATED TO THE REPORTED COMPLAINT AND THERE WAS NO PREVIOUS HISTORY OF COMPLAINT REPORTED FOR AUTOPULSE WITH SERIAL NUMBER (B)(4).

    Description of Event or Problem · 1

    DURING SHIFT CHECK, THE LCD BACKLIGHT OF THE AUTOPULSE PLATFORM (SN (B)(4)) HAS FLICKERING LIGHT. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    885940 AUTOPULSE® RESUSCITATION MODEL 100 CARDIAC CHEST COMPRESSOR DRM ZOLL CIRCULATION MODEL 100 00849111000772

    Patients

    Seq Age Sex Outcome Treatment
    1