BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD-PAK

    MDR report key: 8627228 · Received May 21, 2019

    Report

    Report Number
    3004123209-2019-00202
    Event Type
    Malfunction
    Date Received
    May 21, 2019
    Date of Event
    May 1, 2019
    Report Date
    February 4, 2020
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K014067
    Removal / Correction Number
    Z-0124-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORDS FOR THE SAM 300P DEVICE AND THE PAD-PAK WERE REVIEWED, AND THIS CONFIRMED THAT ALL MANUFACTURING AND QUALITY CHECKS AND TEST HAD BEEN SUCCESSFULLY COMPLETED, THE DEVICE WAS PREVIOUSLY RETURNED TO HEATSINE FOR UPGRADE. THE UPPER CASE ASSEMBLY AND MEMBRANE WERE REWORKED, AND THE DEVICE WAS RETESTED. THE SAM 300P LAST PASSED ¿OUT QAT FROM HEARTSINE TECHNOLOGIES ON THE (B)(6) 2014. THE DEVICE WAS RETURNED WITH A REPORTED FAULT OF A SPEAKER MALFUNCTION DETECTED DURING SAVER EVO TESTING. INFORMATION FROM THE HISTORY LOG SHOWED THE DEVICE HAD PERFORMED AS PER SPECIFICATION FROM INSTALLATION UP UNTIL THE LAST LOG ENTRY ON THE (B)(6) 2019. DURING TESTING AT HEARTSINE, THE DEVICE PASSED THE ¿AUDIBLE BEEP¿ TEST WITHIN THE SAVER EVO DIAGNOSTIC TOOL MULTIPLE TIMES WITHOUT FAULT. FURTHERMORE, THE DEVICE ISSUED ALL SPECIFIED AUDIO PROMPTS THROUGHOUT THE INVESTIGATION, WITH NO OMISSIONS, DISTORTION OR OTHER ABNORMALITIES IDENTIFIED. MEASUREMENTS WERE TAKEN ON THE SPEAKER, USB POWER CIRCUITRY AND SPEECH CIRCUITRY, WITH NO FAULT FOUND. THE DEVICE WAS LEFT IN THE HUMIDITY CHAMBER FOR 5 DAYS AT 50°C 95%RH. THE UNIT WAS POWER CYCLED MULTIPLE TIMES DURING AND AFTER THIS STRESS TESTING, ISSUING THE NORMAL ADVISORY SPEECH PROMPTS ON EACH OCCASION AND PASSING THE AUDIBLE BEEP TEST WITHIN SAVER EVO DIAGNOSTIC TOOL. FURTHERMORE, NO MEASURABLE FAULT WAS IDENTIFIED ON THE UNIT, EVEN AFTER THE STRESS OF ELEVATED TEMPERATURE AND HUMIDITY. THE INVESTIGATION WAS UNABLE TO CONFIRM THE REPORTED FAULT. THE SAVER EVO TEST REQUIRES A USB CABLE TO BE CONNECTED TO THE USB PORT ON THE USER¿S PC. THE INVESTIGATION WAS UNABLE TO VERIFY EITHER THE USERS USB CABLE OR THE USB PORT ON THE USER¿S PC WHICH MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE. THE RETURNED SAM 300P IS NOW OUTSIDE OF ITS WARRANTY PERIOD AND WILL BE SCRAPPED.

    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

    SPEAKER IS MALFUNCTIONIN. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

    Description of Event or Problem · 0

    SPEAKER IS MALFUNCTION. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421814 HEARTSINE SAMARITAN 300P AND PAD-PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1