BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD-PAK

    MDR report key: 8486098 · Received April 5, 2019

    Report

    Report Number
    3004123209-2019-00145
    Event Type
    Malfunction
    Date Received
    April 5, 2019
    Date of Event
    April 1, 2019
    Report Date
    May 24, 2019
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K014067
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SG
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORDS FOR THE SAM 300P DEVICE AND PAD-PAK WERE REVIEWED AND THIS CONFIRMED THAT ALL MANUFACTURING AND QUALITY CHECKS AND TEST HAD BEEN SUCCESSFULLY COMPLETED. THE SAM 300P PASSED ¿OUT QAT FROM HEARTSINE TECHNOLOGIES ON THE 5TH JULY 2012. THE DEVICE WAS RETURNED FOR ¿RED STATUS INDICATOR FLASHING WITH PAD-PAK EXPIRY AUG 2021¿. THROUGHOUT THE HISTORY LOG THE DEVICE RECORDS MULTIPLE MANUAL POWER ONS OF 10 MINUTES DURATION WHICH LEAD TO THE DEPLETION OF MULTIPLE PAD-PAKS CAUSING THE USER TO BE ALERTED WITH A ¿WARNING, LOW BATTERY, DEVICE SERVICE REQUIRED¿ PROMPT AND A FLASHING RED STATUS LED, AS PER THE REPORTED FAULT. THE FAULT WAS TRACED BACK TO THE CORROSION OBSERVED ON THE MEMBRANE TAIL AND THE J11 CONNECTOR. THE CURRENT DRAIN RETURNED TO A LEVEL OF A KNOWN GOOD DEVICE WHEN THE CORROSION WAS CLEARED FROM THE MEMBRANE TAIL. THIS WOULD CONFIRM THE FAILURE OF THE RETURNED MEMBRANE DUE TO THE CORROSION ON THE MEMBRANE TAIL AS A RESULT OF SUSPECTED STORAGE OUTSIDE THE INDICATED CONDITIONS. HOWEVER, THIS COULD NOT BE VERIFIED BY OTHER MEANS; I.E NO CORROSION ON SCREWS OR USB CONTACT COLLARS OR ELSEWHERE WITHIN THE DEVICE. FURTHERMORE AFTER REMOVING THE CORROSION FROM THE MEMBRANE TAIL AND THE J11 CONNECTOR, THE DEVICE WAS TEMPERATURE CYCLED BETWEEN 0°C AND 50°C FOR 48 HOURS WHILE PERFORMING A SELF-TEST EVERY 20 MINUTES. THIS IS EQUIVALENT TO APPROXIMATELY 33 MONTHS OF NORMAL USE WITHOUT FAULT. 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 REPLACED WITH A 350P.

    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

    RED STATUS INDICATOR FLASHING WITH PAD-PAK EXPIRY AUG 2021. NO PATIENT INVOLVED.

    Description of Event or Problem · 0

    RED STATUS INDICATOR FLASHING WITH PAD-PAK EXPIRY AUG 2021. NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282693 HEARTSINE SAMARITAN 300P AND PAD-PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1