BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACKAGE,500P,PP03,INTL EN,500-BAS-UK-10

    MDR report key: 7730934 · Received July 30, 2018

    Report

    Report Number
    3004123209-2018-00496
    Event Type
    Malfunction
    Date Received
    July 30, 2018
    Date of Event
    June 20, 2018
    Report Date
    September 19, 2018
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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).

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORDS FOR THE SAM 500P DEVICE AND PAD-PAK WERE REVIEWED AND THIS CONFIRMED THAT ALL MANUFACTURING AND QUALITY CHECKS AND TEST HAD BEEN SUCCESSFULLY COMPLETED. THE SAM 500P PASSED ¿OUT QAT FROM HEARTSINE TECHNOLOGIES ON THE 12TH FEBRUARY 2017. THE HISTORY LOG FOR THIS DEVICE SHOWED THAT THE PAD-PAK WAS FIRST INSTALLED ON THE 3RD APRIL 2016 AND PERFORMED TO SPECIFICATION UP TO THE 17TH JUNE 2018. THE REPORTED COMPLAINT CONCERNS THE DEVICE FAILING TO POWER UP DURING A PATIENT INVOLVED EVENT OCCURRING ON THE 20TH JUNE 2018. THERE WAS NO MANUAL POWER UP RECORDED ON THIS DATE. THE DEVICE WAS SUBSEQUENTLY SUCCESSFULLY POWER CYCLED ON THE 21ST JUNE 2018 FOR APPROXIMATELY TEN SECONDS IN DURATION BEFORE BEING POWERED OFF. THE DEVICE SUCCESSFULLY PERFORMED ALL SUBSEQUENT WEEKLY AUTO SELF-TESTS UP TO THE 5TH AUGUST 2018. THE ELECTRODE POUCH ON THE RETURNED PAD-PAK WAS OBSERVED TO BE OPENED AND THE ELECTRODES REMOVED FROM THE LINER. THERE WERE VISIBLE SIGNS OF HUMAN CONTAMINANTS (INCLUDING HAIR) WHICH WOULD INDICATE USE ON A PATIENT. A VISUAL INSPECTION OF THE PAD-PAK REVEALED NO DEFECTS. THE DEVICE WAS TESTED ON THE CALIBRATED DEFIBRILLATOR ANALYSER USING THE RETURNED PAD-PAK ON THE 5TH SEPTEMBER 2018 AND DELIVERED THE TEST THERAPY SEQUENCE WITHOUT FAULT. NO FAULT WAS FOUND WITH THE DEVICE DURING TESTING AT HEARTSINE EVEN WHEN PLACED UNDER ELEVATED STRESS. GIVEN NO FAULT FOUND WITH THE DEVICE, THE REPORT CAN ONLY CONCLUDE THAT THE PAD-PAK HAD BEEN INCORRECTLY SEATED WITHIN THE DEVICE DURING THE EVENT. AN INCORRECTLY SEATED PAD-PAK WOULD ACCOUNT FOR THE DEVICE FAILING TO ACTIVATE.

    Description of Event or Problem · 0

    THERE WAS NO PATIENT INVOLVED. DEVICE DID NOT SWITCH ON. DEFIBRILLATOR AT (B)(6) THAT WAS USED ON THE (B)(6). THEY CLAIM IT DID NOT GO ON BUT WE WONDER IF THEY REMOVED THE COMPLETE PAD-PAK.

    Description of Event or Problem · 0

    THERE WAS NO PATIENT INVOLVED. DEVICE DID NOT SWITCH ON. DEFIBRILLATOR AT AUSTRALIAN PARLIAMENT HOUSE THAT WAS USED ON THE 20TH OF JUNE. THEY CLAIM IT DID NOT GO ON BUT WE WONDER IF THEY REMOVED THE COMPLETE PAD-PAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575142 PACKAGE,500P,PP03,INTL EN,500-BAS-UK-10 AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1