BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSTART ADULT/CHILD PLUS PADS

    MDR report key: 11921869 · Received June 2, 2021

    Report

    Report Number
    3030677-2021-11933
    Event Type
    Death
    Date Received
    June 2, 2021
    Date of Event
    May 7, 2021
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MKJ
    PMA / PMN Number
    P160028
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS OBSERVED THAT THE GEL ON THE PADS HAD PEELED DURING THE PATIENT USE EVENT AND WAS NOT MISSING AS FIRST REPORTED, HOWEVER PADS WERE ABLE TO SUCCESSFULLY ADMINISTER 3 SHOCKS DURING INVESTIGATION/TESTING.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THE FIRE DEPARTMENT USED THE HEARTSTART ADULT/CHILD PLUS PAD BUT THERE WAS NO GEL ON THE PAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819278 HEARTSTART ADULT/CHILD PLUS PADS PADS MKJ PHILIPS NORTH AMERICA LLC M3713A 062620-01

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death