BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 5090462 · Received September 21, 2015

    Report

    Report Number
    3004123209-2015-01183
    Event Type
    Malfunction
    Date Received
    September 21, 2015
    Date of Event
    September 8, 2015
    Report Date
    October 13, 2015
    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
    IA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PAD-PAK WAS FIRST INSTALLED SUCCESSFULLY IN APRIL 2010 AND ALL SELF-TESTS, ALONGSIDE RANDOM MANUAL POWER ONS, UP TO THE 9TH AUGUST 2015. MULTIPLE MANUAL POWER UPS OF TEN MINUTES DURATION WERE RECORDED DURING THIS TIME AND THEN BETWEEN THE 14TH AUGUST 2015 AND THE LAST LOG ENTRY ON THE 8TH SEPTEMBER 2015. AN INCREASE IN VOLTAGE SUGGESTS A FURTHER PAD-PAK WAS INSTALLED DURING THIS TIME. 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.

    Description of Event or Problem · 1

    THERE WAS NO PATIENT INVOLVED IN THIS EVENT. UNIT POWERS ON BY ITSELF WITHOUT MANUAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622194 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM

    Patients

    Seq Age Sex Outcome Treatment
    1