BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACKAGE,350P,PP03,USB,IS,350-BAS-IS-10

    MDR report key: 8590303 · Received May 8, 2019

    Report

    Report Number
    3004123209-2019-00167
    Event Type
    Malfunction
    Date Received
    May 8, 2019
    Date of Event
    April 1, 2019
    Report Date
    June 24, 2019
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    UDI-DI
    M727SAM350P
    PMA / PMN Number
    P160008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORDS FOR THE SAM 350P DEVICE WAS 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 ATTRIBUTED TO EXCESS SILICONE ON THE MEMBRANE TAIL AND UPPER CASE, WHICH HAD POSITIONED THE TAIL AROUND A TIGHTER BEND. THIS HAD PLACED ADDITIONAL STRESS ON THE TRACKS, RESULTING IN AN INTERMITTENT CONNECTION ON TRACK 4 (GREEN STATUS LED). AS THE OPERATION OF ALL THE LEDS WERE VERIFIED DURING FINAL UNIT TEST, (B)(4), IT IS CONCLUDED THAT THE ADDITIONAL STRESS ON TRACK 4 HAD RESULTED IN REDUCED CONDUCTIVITY ON THIS TRACK OVER TIME. THE LOW TEMPERATURES RECORDED IN THE HISTORY LOG WOULD INDICATE THAT THE DEVICE WAS 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.

    Additional Manufacturer Narrative · 0

    XEMPTION NUMBER E2015058. HEARTSINE TECHNOLOGIES LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF HEARTSINE TECHNOLOGIES LLC (IMPORTER).

    Description of Event or Problem · 0

    NO STATUS INDICATOR FLASHING WITH PAD-PAK WITH EXPIRY 2022-09-01. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

    Description of Event or Problem · 0

    NO STATUS INDICATOR FLASHING WITH PAD-PAK WITH EXPIRY 2022-09-01. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386452 PACKAGE,350P,PP03,USB,IS,350-BAS-IS-10 AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD M727SAM350P

    Patients

    Seq Age Sex Outcome Treatment
    1