BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD-PAK

    MDR report key: 7344465 · Received March 16, 2018

    Report

    Report Number
    3004123209-2018-00232
    Event Type
    Malfunction
    Date Received
    March 16, 2018
    Date of Event
    March 13, 2018
    Report Date
    May 28, 2018
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K014067
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    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. NO REWORK WAS CONDUCTED. THE SAM 300P PASSED ¿OUT QAT FROM HEARTSINE TECHNOLOGIES ON THE (B)(6) 2013. A VISUAL INSPECTION OF THE DEVICE REVEALED NO APPARENT DEFECTS. THE DEVICE HISTORY AND MEMORY LOGS WERE DOWNLOADED. THE HISTORY LOG FOR THIS DEVICE SHOWED THAT THE PAD-PAK WAS FIRST INSTALLED ON THE (B)(6) 2013 AND PERFORMED ALL WEEKLY AUTO SELF-TESTS UP TO THE (B)(6) 2018. DURING THIS TIME INFORMATION FROM THE HISTORY LOG SHOWS AN INCREASE IN VOLTAGE WHICH SUGGESTS A FURTHER PAD-PAK WAS INSTALLED. NO FURTHER LOG ENTRIES WERE RECORDED PRIOR TO RECEIPT AT HEARTSINE. THE RETURNED PAD-PAK WAS INSERTED INTO THE DEVICE AND SUCCESSFULLY PASSED A SELF-TEST DURING A MANUAL POWER CYCLE. THE GREEN STATUS INDICATOR WAS OBSERVED FLASHING GREEN ALONG WITH AN AUDIBLE CHIRP THROUGHOUT. NO WARNINGS WERE GIVEN AT SHUTDOWN AND THE STATUS LED CONTINUED TO FLASH GREEN WITH AN AUDIBLE CHIRP. THE DEVICE WAS DISASSEMBLED TO INVESTIGATE. FURTHER INVESTIGATION FOUND THE REPORT FAULT COULD BE ATTRIBUTED TO A SHORT CIRCUIT BETWEEN TRACK 1 (RED STATUS LED) AND TRACK 5 (STATUS LED A) OF THE MEMBRANE DUE TO OVER APPLICATION OF SILVER PASTE. DURING THE INVESTIGATION, THE STATUS LED WAS OBSERVED TO BE FLASHING GREEN AND BEEPING, THIS WOULD CONFIRM THE REPORTED FAULT. THIS IS DUE TO A SHORT CIRCUIT BETWEEN THE ANODE AND CATHODE OF THE RED STATUS LED RESULTING IN LEAKAGE CURRENT TO BEEPER BP1. THE FAULT WAS REPLICATED WITH USE OF A KNOWN GOOD MEMBRANE AND WIRE LINK. THE STATUS LED¿S ARE TESTED DURING H017-014-104 FINAL TEST. THEREFORE, IT IS 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 SHORT CIRCUIT WAS SEEN ON THE MEMBRANE. THE FAULT COULD NOT BE REPLICATED WITH A NEW MEMBRANE FITTED. THE DEVICE WAS STILL ABLE TO DELIVER THE TEST THERAPY SEQUENCE WITHOUT FAULT DURING TESTING AT HEARTSINE. 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 ENDUSER ALLEGES THAT SAM300P UNIT HAS FLASHING GREEN STATUS INDICATOR LIGHT AND IS BEEPING.

    Description of Event or Problem · 0

    NO PATIENT INVOLVED ENDUSER ALLEGES THAT SAM300P UNIT HAS FLASHING GREEN STATUS INDICATOR LIGHT AND IS BEEPING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190255 HEARTSINE SAMARITAN 300P AND PAD-PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1