BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACKAGE,350P,PP01,EN,350-STR-US-10

    MDR report key: 20186824 · Received September 10, 2024

    Report

    Report Number
    3004123209-2024-00161
    Event Type
    Malfunction
    Date Received
    September 10, 2024
    Date of Event
    June 28, 2024
    Report Date
    November 25, 2024
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    UDI-DI
    05060167120671
    PMA / PMN Number
    P160008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    003

    Narratives

    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. HEARTSINE CONTACTED THE CUSTOMER TO REQUEST ADDITIONAL INFORMATION ON THE PATIENT. NO RESPONSE HAS BEEN RECEIVED FROM THE CUSTOMER. PATIENT FIELDS IN WHICH INFORMATION IS NOT PROVIDED WERE INTENTIONALLY LEFT BLANK.

    Additional Manufacturer Narrative · 0

    HEARTSINE'S INVESTIGATION WAS UNABLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED FAULT. THE EVENT MEMORY HAD BEEN ERASED PRIOR TO RECEIPT AT HEARTSINE, THEREFORE THERE WAS LIMITED DATA TO REVIEW. HOWEVER, THE INVESTIGATION WAS ABLE TO CONFIRM THAT THE DEVICE CYCLED BETWEEN "PADS ON" AND "PADS OFF" COMMENTS DURING A PATIENT INVOLVED EVENT. THE DEVICE ALSO APPEARED TO POWER OFF USING THE NORMAL SHUTDOWN SEQUENCE. NO FAULT WAS FOUND ON THE 350P THAT WOULD HAVE LED TO AN UNSTABLE PATIENT IMPEDANCE MEASUREMENT. THE DEVICE CORRECTLY MEASURED PATIENT IMPEDANCES AND DELIVERED SHOCKS TO SPECIFICATION THROUGHOUT THE INVESTIGATION. THE DEVICE SHALL BE RETAINED BY HEARTSINE AND THE CUSTOMER WAS PROVIDED WITH A REPLACEMENT DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED HEARTSINE TO REPORT THAT THEIR DEVICE FAILED TO POWER ON DURING A PATIENT INVOLVED EVENT. IN THIS STATE THE DEVICE WOULD BE INOPERABLE AND DEFIBRILLATION THERAPY WOULD NOT BE AVAILABLE IF NEEDED. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED HEARTSINE TO REPORT THAT THEIR DEVICE FAILED TO POWER ON DURING A PATIENT INVOLVED EVENT. IN THIS STATE THE DEVICE WOULD BE INOPERABLE AND DEFIBRILLATION THERAPY WOULD NOT BE AVAILABLE IF NEEDED. THIS ISSUE IS PATIENT RELATED; HOWEVER THERE WAS NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2022263 PACKAGE,350P,PP01,EN,350-STR-US-10 AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ HEARTSINE TECHNOLOGIES LTD 350P 05060167120671

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown