BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 5976292 · Received September 26, 2016

    Report

    Report Number
    3004123209-2016-01312
    Event Type
    Malfunction
    Date Received
    September 26, 2016
    Date of Event
    September 1, 2016
    Report Date
    October 17, 2016
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K041067
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    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). H3 OTHER TEXT : NOT YET RETURNED TO MANUFACTURER

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2015058. THE HISTORY LOG SHOWED THE PAD-PAK WAS FIRST INSTALLED SUCCESSFULLY ON THE 14TH JULY 2014 AND ALL SELF-TESTS UP TO AND INCLUDING THE LAST LOG ENTRY ON THE 4TH SEPTEMBER 2016. A TEMPERATURE IS RECORDED BELOW THE RECOMMENDED MINIMUM STANDBY TEMPERATURE. A TEST PAD-PAK WAS INSERTED INTO THE DEVICE AND THE DEVICE PASSED A SELF-TEST. THE GREEN STATUS LEDS WERE OBSERVED TO BE FLASHING DURING THE POWER UP WHILST EMITTING A FAILURE CHIRP. NO WARNINGS WERE GIVEN AT SHUTDOWN AND THE STATUS LED CONTINUED TO FLASH GREEN WHILE EMITTING A FAILURE CHIRP. THIS WOULD INDICATE A FAULT. THE DEVICE DELIVERED A TEST SHOCK WITHOUT FAULT AND AN ACCEPTABLE MEASUREMENT WAS RECORDED FOR THE SHOCK. INVESTIGATION FOUND A SHORT CIRCUIT BETWEEN THE GREEN AND RED STATUS LEDS DUE TO OVER APPLICATION OF SILVER PASTE. THE STATUS LED FLASHING GREEN AND BEEPING CAN BE ATTRIBUTED TO THE SHORT CIRCUIT WHICH RESULTED IN LEAKAGE CURRENT TO THE BEEPER. THE STATUS LEDS ARE TESTED DURING FINAL TEST, IT IS THEREFORE CONCLUDED THAT THE SHORT CIRCUIT WAS INTERMITTENT IN NATURE AND CAUSED AS A RESULT OF AN OVER APPLICATION OF SILVER PASTE DURING THE MANUFACTURING PROCESS. THE FAULT COULD NOT BE REPLICATED WITH A NEW MEMBRANE FITTED. THE INVESTIGATION WAS UNABLE TO REPLICATE OR FIND CONCLUSIVE EVIDENCE OF THE DEVICE SWITCHING ON AUTOMATICALLY.

    Description of Event or Problem · 0

    THERE WAS NO PATIENT INVOLVED IN THIS EVENT. PAD UNIT POWERS ON BY ITSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628332 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM N/A

    Patients

    Seq Age Sex Outcome Treatment
    1