BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 500P AND PAD-PAK

    MDR report key: 8472476 · Received April 2, 2019

    Report

    Report Number
    3004123209-2019-00133
    Event Type
    Malfunction
    Date Received
    April 2, 2019
    Date of Event
    April 1, 2019
    Report Date
    May 22, 2019
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SG
    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

    THE DEVICE HISTORY RECORDS FOR THE SAM 500P DEVICE AND PAD-PAK WERE REVIEWED AND THIS CONFIRMED THAT ALL MANUFACTURING AND QUALITY CHECKS AND TEST HAD BEEN SUCCESSFULLY COMPLETED. THE SAM 500P PASSED ¿OUT QAT¿ FROM HEARTSINE TECHNOLOGIES ON THE (B)(6) 2013. DURING THE INVESTIGATION, THE DEVICE WAS FOUND TO BE GIVING INCORRECT CHILD PATIENT PROMPTS WITH AN ADULT PAD-PAK INSTALLED, THIS WOULD CONFIRM THE REPORTED FAULT. THE MEASUREMENTS TAKEN WOULD INDICATE A FAILURE OF THE REED SWITCH (SW1). ON THE 1ST APRIL 2019 THE DEVICE RECORDS A MANUAL POWER ON AND INFORMATION FROM THE TECHNICAL LOG SHOWS THAT ON THIS OCCASION THE DEVICE PROMPTED ¿CHILD PATIENT¿. THIS WOULD INDICATE THAT THE FAULT WAS DETECTED DURING THIS MANUAL POWER CYCLE. THE USER ACCESSIBLE MEMORY WAS ERASED PRIOR TO THIS DATE THEREFORE NO INFORMATION CAN BE OBTAINED BEFORE THIS DATE. THE REED SWITCH WAS REPLACED AND THE DEVICE POWER CYCLED MULTIPLE TIMES WITH BOTH AN ADULT PAD-PAK AND PAEDIATRIC-PAK. THE DEVICE GAVE ADULT VOICE PROMPTS WITH THE ADULT PAD-PAK INSTALLED AND CHILD VOICE PROMPTS WITH THE PEDI-PAK INSTALLED. AS DETAILED IN THE REPORT THE DEVICE WAS CAPABLE OF DELIVERING THERAPY, HOWEVER, THE SHOCK ENERGY MAY HAVE BEEN REDUCED FOR HIGHER IMPEDANCE PATIENTS DUE TO THE DEVICE POWERING UP IN PAEDIATRIC MODE. IN ADDITION, THE ABILITY OF THE DEVICE TO DETECT PATIENT IMPEDANCE <74 WOULD HAVE BEEN COMPROMISED. 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 ANOTHER DEVICE OF THE SAME MODEL.

    Description of Event or Problem · 0

    GREEN STATUS INDICATOR FLASHING, DEVICE PROMPTED CHILD PATIENT WITH ADULT PAD-PAK FITTED. NO PATIENT INVOLVED.

    Description of Event or Problem · 0

    GREEN STATUS INDICATOR FLASHING, DEVICE PROMPTED CHILD PATIENT WITH ADULT PAD-PAK FITTED. NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268529 HEARTSINE SAMARITAN 500P AND PAD-PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1