BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FR3, REFURB ECG AED - UK ENGLISH

    MDR report key: 8489988 · Received April 7, 2019

    Report

    Report Number
    3030677-2019-00735
    Event Type
    Malfunction
    Date Received
    April 7, 2019
    Report Date
    March 20, 2019
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K130684
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT NUMBER CORRECTED FROM 861388 TO 861389.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE DEVICE IS FAILING SELF-TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283087 FR3, REFURB ECG AED - UK ENGLISH AED MKJ PHILIPS MEDICAL SYSTEMS 861389

    Patients

    Seq Age Sex Outcome Treatment
    1