BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD-PAK

    MDR report key: 7302071 · Received February 28, 2018

    Report

    Report Number
    3004123209-2018-00162
    Event Type
    Malfunction
    Date Received
    February 28, 2018
    Date of Event
    February 1, 2018
    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
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2015058. HEARTSINE TECHNOLOGIES LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON TECHNOLOGIES LLC (IMPORTER BEHALF OF HEARTSINE) H3 OTHER TEXT: NOT RETURNED YET.

    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 (B)(6) 2011. THE HISTORY LOG FOR THIS DEVICE SHOWED THAT THE PAD-PAK WAS FIRST INSTALLED ON THE (B)(6) 2011 AND PERFORMED TO SPECIFICATION UP TO THE (B)(6) 2017. ON THE (B)(6) 2017, THE DEVICE FAILED THE WEEKLY AUTO SELF-TEST DUE TO A LOW BATTERY. INFORMATION FROM THE HISTORY LOG SHOWS A SIGNIFICANT DECREASE IN VOLTAGE FROM THE PREVIOUS SUCCESSFUL SELF-TEST. THE USER WOULD HAVE BEEN ALERTED WITH A ¿WARNING, LOW BATTERY, DEVICE SERVICE REQUIRED¿ PROMPT AND A FLASHING RED STATUS LED. THE DEVICE WAS STILL IN FAULT MODE ON THE (B)(6) 2017, WHEN INFORMATION FROM THE HISTORY LOG SHOWS AN INCREASE IN VOLTAGE AND THE DEVICE WAS POWER CYCLED PASSING A SELF-TEST. THE DEVICE SUCCESSFULLY PERFORMED ALL SUBSEQUENT WEEKLY AUTO SELF-TESTS UP TO THE (B)(6) 2017. ON THE (B)(6) 2017, THE DEVICE FAILED THE WEEKLY AUTO SELF-TEST DUE TO A LOW BATTERY, ALONGSIDE A LOG ENTRY OF NONSENSICAL DATA. INFORMATION FROM THE HISTORY LOG SHOWS A SIGNIFICANT DECREASE IN VOLTAGE FROM THE PREVIOUS SUCCESSFUL SELF-TEST. NO FURTHER LOG ENTRIES WERE RECORDED. THE DEVICE WAS TESTED ON THE CALIBRATED IMPULSE DEFIBRILLATOR ANALYSER E DEVICE DELIVERED A TEST SHOCK WITHOUT FAULT. NO WARNINGS WERE GIVEN AT SHUTDOWN AND THE GREEN STATUS LED REMAINED CONSTANTLY LIT. THE DEVICE WAS DISASSEMBLED TO INVESTIGATE. THE TOP LAYERS OF THE MEMBRANE WERE PEELED BACK TO VISUALLY INSPECT THE TRACKS WITHIN THE MEMBRANE. UPON VISUAL INSPECTION, CORROSION WAS OBSERVED ON BOTH THE SHOCK KEY DOME AND THE ON/OFF DOME. THIS WOULD SUGGEST THE DEVICE HAD BEEN SUBJECT TO MOISTURE INGRESS. THE MEASUREMENTS TAKEN DURING THE INVESTIGATION, INCLUDING AN EXCESS CURRENT DRAIN, WOULD CONFIRM A FAILING MEMBRANE. A LEAKAGE MEASURED BETWEEN TRACK 5 AND TRACK 10 AND THE EVIDENCE OF CORROSION OBSERVED WITHIN THE MEMBRANE WOULD SUGGEST THE DEVICE HAD BEEN SUBJECT TO MOISTURE INGRESS, RESULTING IN A BREAKDOWN OF THE TRACKS WITHIN THE MEMBRANE DUE TO CORROSION. THERE WAS NO CONCLUSIVE EVIDENCE RECORDED IN THE HISTORY LOG OF THE DEVICE SWITCHING ITSELF ON AUTOMATICALLY, AS PER THE REPORTED FAULT (I.E. MULTIPLE MANUAL POWER UPS, MAINLY OF TEN-MINUTE DURATION), HOWEVER, THIS MAY HAVE BEEN A FURTHER SYMPTOM OF A FAILING MEMBRANE. THE LOW BATTERY FAILS AT THE END OF THE HISTORY LOG MAY BE ATTRIBUTED TO THE EXCESS CURRENT DRAIN. THE CORROSION OBSERVED WOULD SUGGEST THE DEVICE HAD BEEN STORED IN ADVERSE CONDITIONS, HOWEVER, THIS COULD NOT BE VERIFIED BY OTHER MEANS. AS THIS IS A PREVIOUS REVISION MEMBRANE WITH EVIDENCE OF MOISTURE INGRESS NO FURTHER INVESTIGATION WILL BE CARRIED OUT. SUBSEQUENT REVISIONS OF THIS MEMBRANE INCLUDE A WATERPROOF GASKET TO REDUCE THE LIKELIHOOD OF MOISTURE INGRESS. 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 SAM 350P.

    Description of Event or Problem · 0

    NO PATIENT INVOLVED. DEVICES SWITCHING ON AUTOMATICALLY.

    Description of Event or Problem · 0

    NO PATIENT INVOLVED. DEVICES SWITCHING ON AUTOMATICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147460 HEARTSINE SAMARITAN 300P AND PAD-PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1