BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD-PAK

    MDR report key: 7420575 · Received April 11, 2018

    Report

    Report Number
    3004123209-2018-00246
    Event Type
    Malfunction
    Date Received
    April 11, 2018
    Date of Event
    March 23, 2018
    Report Date
    August 29, 2018
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K014067
    Removal / Correction Number
    Z-0124-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 RECORDS 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 5TH DECEMBER 2004. FAILURE OF TRANSFORMER T1. THE DEVICE WAS RETURNED FOR ¿DEVICE WONT SWITCH ON¿. THE FAILURE OF T1 RESULTED IN AN EXCESS CURRENT BEING DRAWN THROUGH R32 CAUSING DAMAGE TO THE COMPONENT. THIS EXCESS CURRENT HAD ALSO RESULTED IN THE 18V LINE DIPPING LOW AND RESULTED IN THE DEVICE FAILING TO POWER ON AS PER THE REPORTED FAULT. THE FAULTS COULD NOT BE REPLICATED WHEN T1 WAS REPLACED, THIS WOULD CONFIRM A FAULT WITH THE ORIGINAL T1. AS THE LAST MEMORY LOG ENTRY WAS ON THE 4TH MARCH 2018 AND THE FAILURE OF T1 WOULD HAVE RESULTED IN DEVICE NOT POWERING ON AND THEREFORE NOT RECORDING ANY SELF-TESTS. THIS WOULD INDICATE THAT THE FAULT WOULD HAVE OCCURRED AFTER THIS DATE.THE T1 COMPONENT IS NOW DISCONTINUED AND IS NO LONGER USED ON CURRENT DEVICES.THE DEVICE PASSED OUT QAT ON THE 5TH DECEMBER 2004 AND THE FIRST MEMORY LOG ENTRY WAS A LOW BATTERY FAIL ON THE 23RD OCTOBER 2008. FURTHERMORE, THERE WERE NO MEMORY LOG ENTRIES FROM THE 30TH SEPTEMBER 2013 UNTIL A LOW BATTERY FAIL RECORDED ON THE 18TH FEBRUARY 2018. THIS WOULD SUGGEST THAT THE LOW BATTERY FAILS WERE MOST LIKELY DUE TO GRADUAL DEPLETION OF THE INSTALLED PAD-PAKS. THE RETURNED SAM 300P IS NOW OUTSIDE OF ITS WARRANTY PERIOD AND WILL BE SCRAPPED.

    Description of Event or Problem · 0

    DEVICE WILL NOT SWITCH ON WITH KNOWN GOOD PAD-PAK. NO PATIENT INVOLVED.

    Description of Event or Problem · 0

    DEVICE WILL NOT SWITCH ON WITH KNOWN GOOD PAD-PAK. NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263129 HEARTSINE SAMARITAN 300P AND PAD-PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1