BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8041449 · Received November 6, 2018

    Report

    Report Number
    3004123209-2018-00698
    Event Type
    Malfunction
    Date Received
    November 6, 2018
    Date of Event
    October 1, 2018
    Report Date
    January 21, 2019
    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 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 (B)(6) 2013. DURING THE INVESTIGATION, THE GREEN STATUS LED WAS NOT FLASHING, AS PER THE REPORTED FAULT. THE GREEN STATUS LED ON THE MEMBRANE WAS MEASURED AND FOUND TO HAVE FAILED. THIS HAD RESULTED IN THE DEVICE DISPLAYING NO STATUS INDICATOR. THE FAULT COULD NOT BE REPLICATED WHEN THE GREEN STATUS LED WAS REPLACED. THE STATUS LEDS ARE TESTED DURING H032-014-004 FINAL UNIT TEST, THE DEVICE SUCCESSFULLY PASSED FINAL UNIT TEST ON THE (B)(6) 2013. THIS WOULD THEREFORE INDICATE THE COMPONENT FAILED AFTER DISPATCH FROM HEARTSINE. ADDITIONALLY, THE CORROSION ON THE CONTACT COLLARS AND ON THE SCREWS INDICATES THE DEVICE HAD BEEN STORED OUTSIDE THE INDICATED CONDITIONS. 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

    NO STATUS INDICATOR. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

    Description of Event or Problem · 0

    NO STATUS INDICATOR. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    881020 PACKAGE,500P,PP03,INTL EN,500-BAS-SP-10 AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1