BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD-PAK

    MDR report key: 7334291 · Received March 13, 2018

    Report

    Report Number
    3004123209-2018-00219
    Event Type
    Malfunction
    Date Received
    March 13, 2018
    Date of Event
    March 6, 2018
    Report Date
    April 27, 2018
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K014067
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    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: DEVICE NOT RETURNED YET.

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD FOR THE SAM 300P DEVICE WAS REVIEWED AND THIS CONFIRMED THAT ALL MANUFACTURING AND QUALITY CHECKS AND TEST HAD BEEN SUCCESSFULLY COMPLETED. THE SAM 300P PASSED ¿OUT QAT FROM HEARTSINE TECHNOLOGIES ON THE 10TH DECEMBER 2012. A VISUAL INSPECTION OF THE DEVICE REVEALED NO APPARENT DEFECTS. THE DEVICE HISTORY AND MEMORY LOGS WERE DOWNLOADED AND ARE ATTACHED TO THIS REPORT. THE HISTORY LOG FOR THIS DEVICE SHOWED THAT THE PAD-PAK WAS FIRST INSTALLED ON THE 26TH MARCH 2013 AND PERFORMED ALL WEEKLY AUTO SELF-TESTS, ALONGSIDE RANDOM MANUAL POWER ONS, UP TO THE 4TH MARCH 2018. ON THE 29TH SEPTEMBER 2014, THE DEVICE RECORDED A MANUAL POWER ON OF 14 MINUTES DURATION, SUGGESTING THE DEVICE HAD DETECTED AN IN-RANGE PATIENT IMPEDANCE ON THIS OCCASION. HOWEVER, THE USER ACCESSIBLE MEMORY WAS ERASED PRIOR TO RECEIPT AT HEARTSINE, THEREFORE, NO FURTHER INFORMATION COULD BE OBTAINED REGARDING THIS EVENT. DURING THE INVESTIGATION, THE INSTRUCTIONAL LEDS FAILED TO ILLUMINATE, THIS WOULD CONFIRM THE REPORTED FAULT. UPON FURTHER INVESTIGATION, THE MEMBRANE TAIL WAS OBSERVED TO HAVE A DOUBLE FOLD. THIS HAD MOST LIKELY RESULTED IN A BREAK/DAMAGE TO TRACK 10 (3.3V LINE) RESULTING IN THE OBSERVED FAULT. THE DOUBLE FOLD OBSERVED ON THE MEMBRANE TAIL WAS MOST LIKELY DUE TO AN ASSEMBLY ERROR WHICH LED TO THE BREAKDOWN OF THE TRACKS OVER TIME RESULTING IN THE FAULTS OBSERVED. THE STATUS LED¿S ALONG WITH THE FUNCTION OF THE MEMBRANE WHERE TESTED AS PART OF FINAL TEST H017-014-104 ON THE 10TH DECEMBER 2012. THIS WOULD INDICATE THAT THE FOLDED MEMBRANE TAIL HAD CAUSED A LATENT FAILURE OF THE TRACKS THAT HAD DEVELOPED AFTER DISPATCH FROM 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

    END-USER ALLEGES THAT SAM300P UNIT'S ICON LIGHTS ARE NOT WORKING. NO PATIENT INVOLVED.

    Description of Event or Problem · 0

    END-USER ALLEGES THAT SAM300P UNIT'S ICON LIGHTS ARE NOT WORKING. NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179516 HEARTSINE SAMARITAN 300P AND PAD-PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1