BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 500P AND PAD PAK

    MDR report key: 6154220 · Received December 8, 2016

    Report

    Report Number
    3004123209-2016-01819
    Event Type
    Malfunction
    Date Received
    December 8, 2016
    Date of Event
    November 24, 2016
    Report Date
    July 25, 2017
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K041067
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. HEARTSINE TECHNOLOGIES LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF HEARTSINE TECHNOLOGIES LLC (IMPORTER). THE DEVICE HISTORY RECORDS FOR THE RETURNED SAM 300P DEVICE WAS REVIEWED AND THIS CONFIRMED THAT ALL MANUFACTURING AND QUALITY CHECKS AND TESTS HAD BEEN SUCCESSFULLY COMPLETED PRIOR TO THE DESPATCH OF THE SAM 300P FROM HEARTSINE TECHNOLOGIES, BELFAST ON THE (B)(6) 2014. THE HISTORY LOG FOR THIS DEVICE SHOWED THAT THE PAD-PAK WAS FIRST INSTALLED ON THE (B)(6) 2014 AND THAT IT HAD PERFORMED TO SPECIFICATION UP TO THE AUTO SELF-TEST ON THE (B)(6) 2016. THE DEVICE WAS DISASSEMBLED FOR INVESTIGATION AND THE INVESTIGATION FOUND THAT AN INTERNAL COMPONENT HAD FAILED. THE FAILURE OF THIS COMPONENT MOST LIKELY LED TO AN EXCESS CURRENT DRAIN, RESULTING IN THE DEPLETION OF THE COIN CELL. THE DEPLETION OF THIS COIN CELL HAD RESULTED IN THE PAD CLOCK FAILING TO INCREMENT UPON RECEIPT AT HEARTSINE. THE USER WOULD HAVE BEEN ALERTED TO THIS WITH A "WARNING, DEVICE SERVICE REQUIRED" PROMPT AND BY A CONSTANTLY LIT STATUS LED.

    Description of Event or Problem · 0

    THERE WAS NO PATIENT INVOLVED IN THIS EVENT. DEVICE SERVICE REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    807756 HEARTSINE SAMARITAN 500P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM N/A

    Patients

    Seq Age Sex Outcome Treatment
    1