BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART ONSITE

    MDR report key: 10935291 · Received December 2, 2020

    Report

    Report Number
    3030677-2020-01968
    Event Type
    Malfunction
    Date Received
    December 2, 2020
    Report Date
    November 25, 2020
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    UDI-DI
    00884838075849
    PMA / PMN Number
    020715
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION TO BECOME AWARE DATE ONLY FROM 11/25/2020 TO 11/18/2020.

    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
    1402289 HEARTSTART ONSITE AED MKJ PHILIPS MEDICAL SYSTEMS M5066A 00884838075849

    Patients

    Seq Age Sex Outcome Treatment
    1