BEUDAMED
    FDA Adverse Event Death Summary report: N

    HS1 (W B) HOME DEFIB, US ENGLISH, EXCHG

    MDR report key: 14732778 · Received June 17, 2022

    Report

    Report Number
    3030677-2022-03061
    Event Type
    Death
    Date Received
    June 17, 2022
    Date of Event
    March 1, 2022
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MKJ
    UDI-DI
    00884838075849
    PMA / PMN Number
    P160029
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATING EVENT DESCRIPTION AND DEVICE PROBLEM CODE.

    Description of Event or Problem · 0

    THE USER IS REPORTING THE DEVICE DID NOT ADMINISTER A SHOCK. THE PATIENT DID NOT SURVIVE.

    Description of Event or Problem · 0

    THE USER IS REPORTING THE DEVICE DID NOT ADMINISTER A SHOCK AND IT WAS DETERMINED THAT THE PADS ADHESIVE MAY NOT MEET THE CONTACT SURFACE AREA SPECIFICATIONS. THE PATIENT DID NOT SURVIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1311031 HS1 (W B) HOME DEFIB, US ENGLISH, EXCHG AED MKJ PHILIPS NORTH AMERICA LLC M5066A 00884838075849

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Death