BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 2915229 · Received December 20, 2012

    Report

    Report Number
    3004123209-2012-00260
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    October 31, 2012
    Report Date
    November 26, 2012
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K052465
    Removal / Correction Number
    Z-0124-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ROUTINE TESTING CONFIRMED THAT THIS DEVICE WAS INSTALLED BY THE CUSTOMER IN APRIL 2010 AND THAT IT HAD PERFORMED TO SPEC UP TO JAN 2012. ON 22ND JAN 2012, THE DEVICE FAILED A WEEKLY SELF-TEST DUE TO A LOW BATTERY. THE DEVICE WOULD HAVE SWITCHED TO FAULT MODE, WHICH THE CUSTOMER WOULD HAVE BEEN ALERTED TO WITH THE STATUS INDICATOR FLASHING RED AND THE DEVICE EMITTING AN AUDIBLE WARNING MESSAGE. THE DEVICE STAYED IN FAULT MODE FOR THREE MONTHS. ON 9TH APRIL 2012, A NEW PAD-PAK WAS INSTALLED AND THE DEVICE PERFORMED TO SPEC UP TO 13TH JUNE 2012. ON 17TH JUNE 2012, THE DEVICE FAILED THE WEEKLY SELF-TEST BECAUSE OF A LOW BATTERY. THE TESTING PERFORMED ON THIS DEVICE WAS LIMITED BECAUSE THE DEVICE WOULD NOT EXIT FAULT MODE. THE SHOCK TEST WAS ABORTED BECAUSE THE DEVICE SHUT DOWN. FURTHER ANALYSIS DETERMINED A FAULT WITH THE SHOCK BUTTON ON THE MEMBRANE IN THAT THE SHOCK BUTTON REMAINED ACTIVATED. TESTING OF THE TWO PAD-PAKS (LOT 666) CONFIRMED THAT BOTH HAD BEEN SIGNIFICANTLY DEPLETED. THE USE UNTIL DATE OF THE PAD-PAKS (LOT 666) CONFIRMED THAT BOTH HAD BEEN SIGNIFICANTLY DEPLETED. THE USE UNTIL DATE OF THE PAD-PAKS (LOT 666) WAS 06/2013. 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 PT INVOLVED IN THIS EVENT. THIS DEVICE MALFUNCTIONED BECAUSE IT WAS SWITCHING ITSELF ON AUTOMATICALLY. A DEVICE SWITCHING ITSELF ON AUTOMATICALLY, IT LEFT UNDETECTED COULD RESULT IN THE BATTERY BECOMING DEPLETED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1