BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACKAGE,350P,PP03,USB,EN,350-BAS-CN-10

    MDR report key: 9823731 · Received March 12, 2020

    Report

    Report Number
    3004123209-2020-00068
    Event Type
    Malfunction
    Date Received
    March 12, 2020
    Date of Event
    February 16, 2020
    Report Date
    September 7, 2020
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    UDI-DI
    M727SAM350P
    PMA / PMN Number
    P160008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 10TH NOVEMBER 2014. THE DEVICE WAS POWERED ON AND THE USER WAS ISSUED WITH THE ADVISORY SPEECH PROMPTS. THE ELECTRODE PADS WERE ADHERED TO THE PATIENT. THE PATIENT PRESENTED VENTRICULAR FIBRILLATION AND A SHOCK WAS ADVISED. A 150J SHOCK WAS SUBSEQUENTLY DELIVERED. THE DEVICE WAS THEN SWITCHED OFF VIA THE ON/OFF BUTTON. DURING THE EVENT, A NUMBER OF ¿CHECK PADS¿ AUDIO PROMPTS WERE ISSUED. THE INVESTIGATION CONFIRMED THE DEVICES ABILITY TO CORRECTLY MEASURE IMPEDANCE THROUGHOUT THE RANGE EVEN UNDER THE STRESS OF ELEVATED TEMPERATURE. THE ¿CHECK PADS¿ PROMPTS ISSUED DURING THE EVENT MAY HAVE BEEN DUE TO A NUMBER OF THINGS, FOR EXAMPLE, PAD POSITIONING, EXCESSIVE HAIR OR AN INCORRECTLY SEATED PAD-PAK. THE INVESTIGATION WAS UNABLE TO CONFIRM THE REPORTED FAULT. THE DEVICE PERFORMED TO SPECIFICATION DURING THE EVENT. THIS DEVICE SHALL BY RETAINED BY HEARTSINE AS PER COMPLAINT HANDLING PROCEDURE H001-003-080.

    Description of Event or Problem · 0

    WHEN THE AED WAS USED ON SUNDAY, FEBRUARY 16TH AFTER THE FIRST SHOCK WAS GIVEN, THE AED DID NOT CONTINUE TO PROVIDE INSTRUCTIONS. PATIENT INVOLVED; PATIENT SURVIVED TO HOSPITAL ADMISSION.

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER E2015058. (B)(4).

    Description of Event or Problem · 1

    WHEN THE AED WAS USED ON SUNDAY, (B)(6) AFTER THE FIRST SHOCK WAS GIVEN, THE AED DID NOT CONTINUE TO PROVIDE INSTRUCTIONS. PATIENT INVOLVED; PATIENT SURVIVED TO HOSPITAL ADMISSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291116 PACKAGE,350P,PP03,USB,EN,350-BAS-CN-10 AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD SAM 350P M727SAM350P

    Patients

    Seq Age Sex Outcome Treatment
    1