BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 300P AND PAD-PAK

    MDR report key: 7750983 · Received August 6, 2018

    Report

    Report Number
    3004123209-2018-00523
    Event Type
    Malfunction
    Date Received
    August 6, 2018
    Date of Event
    July 1, 2018
    Report Date
    September 4, 2018
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K014067
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2015058. HEARTSINE TECHNOLOGIES LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF HEARTSINE TECHNOLOGIES LLC (IMPORTER). 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. NO REWORK WAS CONDUCTED. THE SAM 300P PASSED ¿OUT QAT¿ FROM HEARTSINE TECHNOLOGIES ON THE 29TH JANUARY 2013. A VISUAL INSPECTION OF THE DEVICE REVEALED NO APPARENT DEFECTS. THE DEVICE HISTORY AND MEMORY LOGS WERE DOWNLOADED. THE HISTORY LOG FOR THIS DEVICE SHOWED THAT THE PAD-PAK WAS FIRST INSTALLED ON THE 13TH MAY 2013 AND PERFORMED TO SPECIFICATION UP TO 29TH APRIL 2018. ON THE 2ND MAY 2018 THE DEVICE RECORDS 3 MANUAL POWER ONS OF UNDER 1 MINUTE DURATION. THESE MANUAL POWER UPS MAY INDICATE THE USER WAS REGULARLY POWER CYCLING THE DEVICE OR THAT THE DEVICE WAS SWITCHING ON AUTOMATICALLY AND THE USER WAS INTERVENING BY TURNING THE DEVICE OFF VIA THE ON/OFF BUTTON. NO FURTHER LOG ENTRIES WERE RECORDED PRIOR TO RECEIPT AT HEARTSINE. THE RETURNED PAD-PAK WAS INSERTED INTO THE DEVICE AND SUCCESSFULLY PASSED AN AUTO SELF-TEST THEN PASSED A SELF-TEST DURING A MANUAL POWER CYCLE. NO WARNINGS WERE GIVEN AT SHUTDOWN AND THE STATUS LED CONTINUED TO FLASH GREEN. THE DEVICE WAS DISASSEMBLED TO INVESTIGATE. THE DEVICE PERFORMED TO SPECIFICATION THROUGHOUT TESTING AT HEARTSINE. DEVICES RETURNED FOR SWITCHING ON AUTOMATICALLY NORMALLY HAVE SYMPTOMS INCLUDING AN EXCESS CURRENT DRAIN AND MULTIPLE MANUAL POWER UPS, MAINLY OF TEN-MINUTE DURATION RECORDED IN THE DEVICE HISTORY LOG. THE DEVICE CURRENT DRAIN WAS VERIFIED DURING THE INVESTIGATION AND THERE WERE NO 10 MINUTE MANUAL POWER ONS RECORDED IN THE HISTORY LOG. THERE WERE 3 MANUAL POWER UPS ON THE 2ND MAY 2018 ALL OF UNDER ONE MINUTE DURATION WHICH MAY HAVE BEEN THE USER POWER CYCLING THE DEVICE PRIOR TO RETURNING IT FOR INVESTIGATION. FURTHERMORE, THE DEVICE WAS TEMPERATURE CYCLED BETWEEN 0-50°C FOR 48 HOURS WHILE PERFORMING A SELF-TEST EVERY 20 MINUTES. THE DEVICE DID NOT TURN ON OR DISPLAY ANY FAULTS. THIS EQUATES TO APPROXIMATELY 33 MONTHS OF NORMAL USE WITHOUT FAULT. THE INVESTIGATION WAS THEREFORE UNABLE TO CONFIRM THE REPORTED FAULT. 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 A HEARTSINE SAM 350P.

    Description of Event or Problem · 0

    DEVICES SWITCHING ON AUTOMATICALLY. THERE WAS NO PATIENT INVOLVED.

    Description of Event or Problem · 0

    DEVICES SWITCHING ON AUTOMATICALLY. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595953 HEARTSINE SAMARITAN 300P AND PAD-PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1