BEUDAMED
    FDA Adverse Event Death Summary report: N

    PACKAGE,500P,PP03,INTL EN,500-BAS-UK-10

    MDR report key: 9762208 · Received February 27, 2020

    Report

    Report Number
    3004123209-2020-00043
    Event Type
    Death
    Date Received
    February 27, 2020
    Date of Event
    February 8, 2020
    Report Date
    February 27, 2020
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2015058. HEARTSINE TECHNOLOGIES LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF HEARTSINE TECHNOLOGIES LLC (IMPORTER).

    Description of Event or Problem · 0

    THIS IS A PATIENT INVOLVED EVENT. THE DEVICE WAS USED DURING AN ALLEGED SCA IN A (B)(6). CPR WAS PERFORMED BY BYSTANDER PRIOR TO SWITCHING ON THE AED. IT WAS REPORTED THAT A SHOCK WAS DELIVERED. INFORMATION RECEIVED BY THE END USER SUGGESTS THAT DEVICE DID NOT PERFORM AS EXPECTED DURING THE ALLEGED SCA. A LOW BATTERY PROMPT WAS NOTED UPON REVIEWING THE SAVER EVO DATA POST EVENT. THE PATIENT DID NOT SURVIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226627 PACKAGE,500P,PP03,INTL EN,500-BAS-UK-10 AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death