BEUDAMED
    FDA Adverse Event Death Summary report: N

    PACKAGE,450P,PP01,EN,450-STR-US-10

    MDR report key: 19630619 · Received June 27, 2024

    Report

    Report Number
    3004123209-2024-00100
    Event Type
    Death
    Date Received
    June 27, 2024
    Date of Event
    May 27, 2024
    Report Date
    August 28, 2024
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    UDI-DI
    05060167120695
    PMA / PMN Number
    P160008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    HEARTSINE'S INVESTIGATION CONFIRMED THE REPORTED FAULT AS THE DEVICE WAS UNABLE TO POWER ON UPON RECEIPT AND THEREFORE ISSUED NO VOICE PROMPTS. THE INVESTIGATION ATTRIBUTED THE REPORTED FAULT TO CORROSION ON THE J12 PIN 13 SOLDER PAD DUE TO STORAGE OUTSIDE OF THE INDICATED CONDITIONS. CORROSION WAS ALSO OBSERVED ACROSS OTHER AREAS OF THE PCBA. THE CUSTOMER WAS PROVIDED WITH A REPLACEMENT DEVICE.

    Additional Manufacturer Narrative · 0

    HEARTSINE TECHNOLOGIES LTD HAS RECEIVED THE DEVICE FOR EVALUATION. WE WILL COMMUNICATE OUR FINDINGS REGARDING THE CAUSE OF THIS EVENT IN OUR FINAL REPORT. THE CUSTOMER PROVIDED HEARTSINE WITH THE AVAILABLE PATIENT INFORMATION. PATIENT FIELDS IN WHICH INFORMATION IS NOT PROVIDED WERE INTENTIONALLY LEFT BLANK.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED HEARTSINE TO REPORT THAT THEIR DEVICE ISSUED NO VOICE PROMPTS DURING A PATIENT INVOLVED EVENT. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THE PATIENT INVOLVED IN THE REPORTED EVENT IS DECEASED.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED HEARTSINE TO REPORT THAT THEIR DEVICE ISSUED NO VOICE PROMPTS DURING A PATIENT INVOLVED EVENT. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THE PATIENT INVOLVED IN THE REPORTED EVENT IS DECEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    816729 PACKAGE,450P,PP01,EN,450-STR-US-10 AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ HEARTSINE TECHNOLOGIES LTD 450P 05060167120695

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Death