BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD-PAK

    MDR report key: 7198704 · Received January 17, 2018

    Report

    Report Number
    3004123209-2018-00084
    Event Type
    Malfunction
    Date Received
    January 17, 2018
    Date of Event
    December 27, 2017
    Report Date
    March 20, 2018
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K014067
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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). H3 OTHER TEXT: DEVICE NOT RETURNED YET.

    Additional Manufacturer Narrative · 0

    A VISUAL INSPECTION OF THE DEVICE REVEALED THAT THERE WAS EVIDENCE OF CORROSION ON THE SCREWS AND USB CONTACT COLLARS OF THE DEVICE. THIS WOULD SUGGEST THE DEVICE HAD BEEN SUBJECT TO ADVERSE STORAGE. THE HISTORY LOG FOR THIS DEVICE SHOWED THAT THE PAD-PAK WAS FIRST INSTALLED SUCCESSFULLY ON THE 16TH MARCH 2015 AND PERFORMED TO SPECIFICATION UP TO THE 28TH FEBRUARY 2016. BETWEEN THE 19TH JUNE 2017 AND THE 5TH SEPTEMBER 2017 THE DEVICE RECORDS MULTIPLE MANUAL POWER ONS OF 10 MINUTES DURATION. MULTIPLE MANUAL POWER ONS OF A RANDOM NATURE AND OF 10 MINUTES DURATION WOULD SUGGEST THE DEVICE WAS SWITCHING ITSELF ON AUTOMATICALLY. THE DEVICE PERFORMED ALL WEEKLY AUTO SELF-TESTS FROM THE 10TH SEPTEMBER 2017 TO THE 24TH SEPTEMBER 2017. ON THE 1ST OCTOBER 2017, THE DEVICE FAILED THE WEEKLY AUTO SELF-TEST DUE TO LOW BATTERY, THE USER WOULD HAVE BEEN ALERTED WITH A ¿WARNING LOW BATTERY, DEVICE SERVICE REQUIRED¿ PROMPT AND A FLASHING RED STATUS LED. THE RETURNED PAD-PAK WAS INSERTED INTO THE DEVICE. THE DEVICE FAILED TO POWER ON. MEASUREMENTS TAKEN DURING THE INVESTIGATION INDICATE THAT THE PAD-PAK WAS DEPLETED BEYOND ANY USE. THE DEVICE WAS TESTED ON THE CALIBRATED IMPULSE DEFIBRILLATOR ANALYSER AND DELIVERED A TEST SHOCK WITHOUT FAULT. THE DEVICE POWERED OFF WITH A ¿WARNING MEMORY FULL¿ PROMPT AND A FLASHING GREEN STATUS LED. THE MEMBRANE WAS REMOVED AND UPON VISUAL INSPECTION CORROSION WAS OBSERVED ON TRACKS 13 (ON BUTTON) OF THE MEMBRANE TAIL . THIS WOULD INDICATE THE DEVICE HAD BEEN SUBJECT TO ADVERSE STORAGE. THIS WOULD CONFIRM A FAILURE OF THE ORIGINAL MEMBRANE DUE TO ADVERSE STORAGE RESULTING IN CORROSION ON THE MEMBRANE TAIL. THE LOW BATTERY FAILS DETAILED IN THE HISTORY LOG WOULD BE EXPLAINED DUE TO THE MULTIPLE MANUAL POWER ONS OF 10 MINUTES DURATION. IT IS THE POLICY OF HEARTSINE NOT TO REFURBISH DEVICES WHICH HAVE BEEN RETURNED FROM THE FIELD, AFTER INVESTIGATION, THEREFORE THIS DEVICE SHALL BE SCRAPPED AND WILL BE REPLACED WITH A HEARTSINE 350P.

    Description of Event or Problem · 0

    DEVICE SWITCHING ON AUTOMATICALLY. NO PATIENT INVOLVED.

    Description of Event or Problem · 0

    DEVICE SWITCHING ON AUTOMATICALLY. NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43268 HEARTSINE SAMARITAN 300P AND PAD-PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1