BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD-PAK

    MDR report key: 7817991 · Received August 27, 2018

    Report

    Report Number
    3004123209-2018-00559
    Event Type
    Malfunction
    Date Received
    August 27, 2018
    Date of Event
    August 1, 2018
    Report Date
    July 30, 2019
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K014067
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORDS FOR THE SAM 300P DEVICE AND PAD-PAK WERE REVIEWED AND THIS CONFIRMED THAT ALL MANUFACTURING AND QUALITY CHECKS AND TEST HAD BEEN SUCCESSFULLY COMPLETED. THE SAM 300P PASSED ¿OUT QAT¿ FROM HEARTSINE TECHNOLOGIES ON THE 1ST MARCH 2011. THE DEVICE WAS RETURNED FOR ¿DEVICE SWITCHING ON AUTOMATICALLY AND MEMORY FULL PROMPTS¿. THROUGHOUT THE HISTORY THE DEVICE RECORDS MULTIPLE MANUAL POWER ONS MAINLY 10 MINUTES DURATION WHICH RESULTED IN THE MEMORY BECOMING FULL AND CAUSING THE USER TO BE ALERTED WITH A ¿WARNING, MEMORY FULL¿ PROMPT. THE FAULT WAS TRACED BACK TO THE CORROSION OBSERVED ON THE MEMBRANE TAIL WHICH WOULD ACCOUNT FOR THE MULTIPLE MANUAL POWER ONS OF MAINLY TEN-MINUTES DURATION RECORDED IN THE HISTORY LOG. THE FAULTS COULD NOT BE REPLICATED WHEN THE CORROSION WAS CLEARED FROM THE MEMBRANE TAIL. THIS WOULD CONFIRM THE FAILURE OF THE RETURNED MEMBRANE DUE TO THE CORROSION ON THE MEMBRANE TAIL. 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

    DEVICE SWITCHING ON AUTOMATICALLY AND PROMPTING MEMORY FULL. NO PATIENT INVOLVED.

    Description of Event or Problem · 0

    DEVICE SWITCHING ON AUTOMATICALLY AND PROMPTING MEMORY FULL. NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662024 HEARTSINE SAMARITAN 300P AND PAD-PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1