BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8013444 · Received October 29, 2018

    Report

    Report Number
    3004123209-2018-00690
    Event Type
    Malfunction
    Date Received
    October 29, 2018
    Date of Event
    October 1, 2018
    Report Date
    December 29, 2018
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    UDI-DI
    M727SAM350P
    PMA / PMN Number
    P160008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 (B)(6)2016 . UPON RECEIPT OF THE DEVICE, THE STATUS INDICATOR WAS FAILING TO ILLUMINATE AS PER THE REPORTED FAULT. THE FAULT WAS TRACED BACK TO INTERMITTENT CONTINUITY ON TRACK 4 (GREEN STATUS LED) OF THE MEMBRANE. IT WAS OBSERVED THAT AN OVER APPLICATION OF SILICON IN THE MEMBRANE TAIL SEAL AREA HAD CAUSED THE TAIL TO FOLLOW A SHARP BEND RATHER THAN THE NORMAL CURVATURE RESULTING IN VISIBLE STRESS MARKS ON TRACK 4. AS THE OPERATION OF ALL THE LEDS WERE VERIFIED DURING FINAL UNIT TEST, H032-014-004, IT IS CONCLUDED THAT THE BREAK IN THE TRACK LIKELY DEVELOPED OVER TIME DUE TO ADDITIONAL STRESS AT THIS BEND. 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 FLASHING. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853102 PACKAGE,350P,PP03,IT,350-BAS-IT-10 AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD M727SAM350P

    Patients

    Seq Age Sex Outcome Treatment
    1