BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 7233414 · Received February 1, 2018

    Report

    Report Number
    3004123209-2018-00124
    Event Type
    Malfunction
    Date Received
    February 1, 2018
    Date of Event
    January 1, 2018
    Report Date
    March 20, 2018
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SG
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2015058. HEARTSINE TECHNOLOGIES LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON TECHNOLOGIES LLC (IMPORTER BEHALF OF HEARTSINE) H3 OTHER TEXT: DEVICE NOT RECIEVED YET.

    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 1ST JULY 2013. THE RETURNED DEVICE WAS UNABLE TO CONNECT VIA USB UPON RECEIPT. UPON INVESTIGATION, THE CONTINUITY OF THE DATA CABLE BLACK (GROUND) WIRE WAS TESTED AND THE WIRE WAS FOUND TO HAVE FAILED. THE FAILURE WAS DUE TO A BREAK IN THE WIRE IN THE CRIMPING AREA, ON THE JP3 CONNECTOR CRIMP. THE DATA CABLE IS ROUTINELY TESTED DURING MANUFACTURING AT HEARTSINE BY TWO METHODS. SECURITY OF THE CONNECTION IS CHECKED DURING ASSEMBLY BY LIGHTLY TUGGING THE CABLE ONCE INSTALLED IN ACCORDANCE WITH DOCUMENT H002-003-045 AND ITS FUNCTION IS THEN TESTED IN ACCORDANCE WITH FINAL TEST SPECIFICATION H017-014-104. RECORDS INDICATE THAT THIS TESTING WAS CARRIED OUT SUCCESSFULLY DURING MANUFACTURE OF THIS UNIT. ADDITIONALLY, THE DEVICE MEMORY WAS ERASED PRIOR TO THE 24TH JANUARY 2017, THE DEVICE WOULD HAVE BEEN CONNECTED TO THE PC VIA USB AT THAT TIME. THEREFORE, IT IS CONCLUDED THAT THIS WIRE HAD PREVIOUSLY MADE SUFFICIENT CONTACT. THIS MAY SUGGEST THE CABLE HAD BEEN POORLY CRIMPED ADDING EXTRA STRESS ON THE WIRE AND ITS CONDITION DETERIORATED OVER TIME. THE DATA CABLE IS ONLY USED FOR USB CONNECTION AND WOULD NOT HAVE AFFECTED THE DEVICES ABILITY TO DELIVER THERAPY AS DEMONSTRATED DURING THE INVESTIGATION. 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 ANOTHER DEVICE OF THE SAME MODEL.

    Description of Event or Problem · 0

    UNABLE TO RUN DIAGNOSTIC TEST OR DOWNLOAD EVENT FROM DEVICE. SAVER EVO CONNECTION ERROR. NO PATIENT INVOLVED.

    Description of Event or Problem · 0

    UNABLE TO RUN DIAGNOSTIC TEST OR DOWNLOAD EVENT FROM DEVICE. SAVER EVO CONNECTION ERROR. NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77535 PACKAGE,500P,PP03,INTL EN,500-BAS-SP-10 AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1