BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAC 5500 HD

    MDR report key: 8008708 · Received October 26, 2018

    Report

    Report Number
    8008708
    Event Type
    Malfunction
    Date Received
    October 26, 2018
    Date of Event
    October 8, 2018
    Report Date
    October 18, 2018
    Manufacturer
    GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
    Product Code
    DPS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    FAILURE OF PART NUMBER 2031810-002 FRU UNIVERSAL WRITER (LOWER CASE OF THE UNIT). THIS FAILURE HAS LEAD TO OTHER DAMAGE INCLUDING THE UNIT WILL POWER ON BUT THE DISPLAY IS BLANK, THE BOTTOM CASE WHERE THE UNIT ATTACHES TO THE TROLLEY IS CRACKED, THE COVER OF THE KEY BOARD IS CRACKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849487 MAC 5500 HD ELECTROCARDIOGRAPH DPS GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES MAC 5500 HD

    Patients

    Seq Age Sex Outcome Treatment
    1