BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACKAGE,350P,PP03,DE,350-BAS-DE-10

    MDR report key: 7730994 · Received July 30, 2018

    Report

    Report Number
    3004123209-2018-00499
    Event Type
    Malfunction
    Date Received
    July 30, 2018
    Date of Event
    July 1, 2018
    Report Date
    October 10, 2018
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    UDI-DI
    M727SAM350P
    PMA / PMN Number
    P160008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 350P DEVICE AND PAD-PAK WERE REVIEWED AND THIS CONFIRMED THAT ALL MANUFACTURING AND QUALITY CHECKS AND TEST HAD BEEN SUCCESSFULLY COMPLETED. THE SAM 350P PASSED ¿OUT QAT¿ FROM HEARTSINE TECHNOLOGIES ON THE 7TH JUNE 2018. DURING THE INVESTIGATION, THE GREEN STATUS LED WAS FLASHING GREEN ALONG WITH A FAINT AUDIBLE CHIRP, AS PER THE REPORTED FAULT. THE RED STATUS LED ON THE MEMBRANE WAS MEASURED AND FOUND TO HAVE FAILED. THIS HAD RESULTED IN A LEAKAGE CURRENT TO BEEPER BP1. THE FAULT COULD NOT BE REPLICATED WHEN THE RED STATUS LED WAS REMOVED FROM THE MEMBRANE. THIS WOULD CONFIRM A CURRENT LEAKAGE ACROSS THE COMPONENT HAD RESULTED IN THE REPORTED FAULT. THE STATUS LEDS ARE TESTED DURING H032-014-004 FINAL UNIT TEST, THE DEVICE SUCCESSFULLY PASSED FINAL UNIT TEST ON THE 7TH JUNE 2018. THIS WOULD THEREFORE INDICATE THE COMPONENT FAILED AFTER DISPATCH FROM HEARTSINE. 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

    THERE WAS NO PATIENT INVOLVED. GREEN STATUS INDICATOR FLASHING AND DEVICE BEEPING.

    Description of Event or Problem · 0

    THERE WAS NO PATIENT INVOLVED. GREEN STATUS INDICATOR FLASHING AND DEVICE BEEPING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573590 PACKAGE,350P,PP03,DE,350-BAS-DE-10 AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD M727SAM350P

    Patients

    Seq Age Sex Outcome Treatment
    1