BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACKAGE,350P,PP01,EN,350-BAS-US-10

    MDR report key: 8407586 · Received March 11, 2019

    Report

    Report Number
    3004123209-2019-00100
    Event Type
    Malfunction
    Date Received
    March 11, 2019
    Date of Event
    March 1, 2019
    Report Date
    August 14, 2019
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    UDI-DI
    M727SAM350P
    PMA / PMN Number
    P160008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    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 12TH AUGUST 2015. SUSPECTED CONTAMINATION WITHIN THE J11 CONNECTOR. UPON RECEIPT, THE RETURNED PAD-PAK FROM LOT: B1236 WAS SEVERELY DEPLETED. INFORMATION FROM THE HISTORY LOG SHOWED THE PAD-PAK WAS FIRST INSTALLED ON THE 16TH NOVEMBER 2015 AND HAD PERFORMED FOR APPROXIMATELY 3 YEARS AND 3 MONTHS PRIOR TO ISSUING THE FIRST LOW BATTERY WARNING ON THE 24TH FEBRUARY 2019. THE USER WOULD HAVE BEEN ALERTED WITH A ¿WARNING LOW BATTERY, DEVICE SERVICE REQUIRED¿ PROMPT AND A FLASHING RED STATUS LED, AS PER THE REPORTED FAULT. DURING INVESTIGATION, FAULTY MEASUREMENTS WERE TAKEN ON THE J11 CONNECTOR, WHICH WOULD HAVE RESULTED IN A LEAKAGE CURRENT FROM THE (STATUS_LED_A) LINE AND DEPLETED THE RETURNED PAD-PAK PRIOR TO ITS EXPIRY OF JANUARY 2020. THE FAULT CLEARED UPON REINSTALLING THE MEMBRANE TAIL, WITH THE J11 MEASUREMENTS THEN REVERTING TO LEVELS COMPARABLE WITH A KNOWN GOOD UNIT. THIS WOULD INDICATE THE FAULTS HAD BEEN CAUSED BY A CONNECTION ISSUE BETWEEN THE MEMBRANE AND J11 CONNECTOR. HOWEVER, NO VISUAL ABNORMALITIES WERE OBSERVED ON THE MEMBRANE TAIL OR WITHIN THE J11 CONNECTOR, THEREFORE IT IS ASSUMED THAT ANY CONTAMINATE WAS DISLODGED WHEN THE MEMBRANE TAIL WAS REINSTALLED. THE RETURNED DEVICE SHALL BE SCRAPPED AND REPLACED WITH A NEW SAM 350P.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    RED STATUS INDICATOR FLASHING AND BEEPING WITH LOW BATTERY PROMPT. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

    Description of Event or Problem · 0

    RED STATUS INDICATOR FLASHING AND BEEPING WITH LOW BATTERY PROMPT. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200221 PACKAGE,350P,PP01,EN,350-BAS-US-10 AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD M727SAM350P

    Patients

    Seq Age Sex Outcome Treatment
    1