BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD PAK

    MDR report key: 6530017 · Received April 28, 2017

    Report

    Report Number
    3004123209-2017-00406
    Event Type
    Malfunction
    Date Received
    April 28, 2017
    Report Date
    August 24, 2017
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K041067
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. HEARTSINE TECHNOLOGIES LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF HEARTSINE TECHNOLOGIES LLC (IMPORTER). THE DEVICE HISTORY RECORDS FOR THE RETURNED SAM 500P 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 500P FROM HEARTSINE TECHNOLOGIES, BELFAST ON THE 22ND AUGUST 2011. THE HISTORY LOG FOR THIS DEVICE SHOWED THAT THE PAD-PAK WAS FIRST INSTALLED ON (B)(6) 2011 AND THAT IT HAD PERFORMED ALL SELF-TESTS UP TO AND INCLUDING THE LAST LOG ENTRY ON (B)(6) 2011. DURING THE ABOVE PERIOD THE DEVICE RECORDS 26 MANUAL POWER ON, MAINLY OF UNDER ONE MINUTE DURATION AND ONE OF NONSENSICAL DURATION. ALSO DURING THIS PERIOD THE DEVICE RECORDS ONE OCCASIONS WHEN THE TEMPERATURE DROPS BELOW THE MINIMUM STANDBY TEMPERATURE OF 0°C, WITH -0.9°C RECORDED. THE DEVICE WAS DISASSEMBLED TO INVESTIGATE AND UPON VISUAL INSPECTION OF THE BOARD A CAPACITOR WAS FOUND TO BE VENTED. THIS WOULD SUGGEST THE CAPACITOR HAD FAILED. THROUGHOUT THE HISTORY LOG THE DEVICE RECORDS MULTIPLE OCCASIONS IN WHICH THE TEMPERATURE IS RECORDED OUTSIDE THE RECOMMENDED OPERATING RANGE OF 0-50°C WITH A LOW OF -2.9°C RECORDED. THE PAD-PAK, WHICH CONTAINS THE ELECTRODES AND BATTERIES, IS LABELLED FOR SINGLE USE BUT THE SAMARITAN PAD 300 AND 300P DEVICES ARE FOR MULTI-USE.

    Description of Event or Problem · 0

    THERE WAS NO PATIENT INVOLVED IN THIS EVENT. DEVICE OBSERVED SWITCHING ON AUTOMATICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313157 HEARTSINE SAMARITAN 300P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM N/A

    Patients

    Seq Age Sex Outcome Treatment
    1