BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 5430145 · Received February 11, 2016

    Report

    Report Number
    3004123209-2016-00166
    Event Type
    Malfunction
    Date Received
    February 11, 2016
    Date of Event
    January 29, 2016
    Report Date
    February 12, 2016
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K041067
    Removal / Correction Number
    Z-0124-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2015058. HEARTSINE TECHNOLOGIES LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF HEARTSINE TECHNOLOGIES LLC (IMPORTER). THE PAD-PAK WAS FIRST INSTALLED SUCCESSFULLY ON THE 11TH MARCH 2010 AND PERFORMED TO SPECIFICATION UP TO THE 17TH MARCH 2013. ON THE 24TH MARCH 2013 THE DEVICE FAILED THE WEEKLY AUTO SELF-TEST DUE TO A LOW BATTERY. THE RECORDED TEMPERATURE ON THIS DATE WAS -2.3 DEGREES CELSIUS. THIS IS BELOW THE RECOMMENDED OPERATING TEMPERATURE FOR THIS DEVICE (0-50 DEGREES CELSIUS). ON 26TH MARCH 2013 A NEW PAD-PAK WAS INSTALLED AND THE DEVICE WAS MANUALLY POWERED UP TWICE PASSING BOTH SELF-TESTS. MULTIPLE MANUAL POWER UPS MAINLY OF TEN MINUTES DURATION WERE OBSERVED BETWEEN THE 20TH SEPTEMBER 2015 AND THE LAST LOG ENTRY ON THE 24TH SEPTEMBER 2015. INVESTIGATION FOUND THE REPORTED FAULT CAN BE ATTRIBUTED TO MEMBRANE FAILURE. THE TEN MINUTE TIME OUTS WOULD SUGGEST A FAILING MEMBRANE. THE FAULT WAS WITNESSED DURING THE INVESTIGATION. THE FAULT COULD NOT BE REPLICATED WITH A NEW MEMBRANE FITTED. THE PAD-PAK, WHICH CONTAINS THE ELECTRODES AND BATTERIES, IS LABELED FOR SINGLE USE BUT THE SAMARITAN PAD 300 AND 300P DEVICES ARE FOR MULTI-USE.

    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 : NOT YET RETURNED TO MANUFACTURER

    Description of Event or Problem · 0

    THERE WAS NO PATIENT INVOLVED IN THIS EVENT. DEVICE SWITCHES ON AUTOMATICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90021 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM N/A

    Patients

    Seq Age Sex Outcome Treatment
    1