BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 500P AND PAD-PAK

    MDR report key: 7721593 · Received July 26, 2018

    Report

    Report Number
    3004123209-2018-00489
    Event Type
    Malfunction
    Date Received
    July 26, 2018
    Date of Event
    June 20, 2018
    Report Date
    September 18, 2018
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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) 2016. UPON RECEIPT THE DEVICE WAS FOUND TO BE FAILING SELF-TESTS DUE TO A SPEECH CHIP LABEL MISMATCH ERROR. THE USER WOULD HAVE BEEN ALERTED WITH A ¿WARNING, DEVICE SERVICE REQUIRED¿ PROMPT ALONGSIDE A FLASHING RED STATUS LED AND FAILURE CHIRP, CONFIRMING THE REPORTED FAULT. VISUAL INSPECTION REVEALED THE MEMBRANE TAIL WAS NOT CORRECTLY ALIGNED WITHIN THE J11 CONNECTOR, WHICH HAD RESULTED IN THE MISALIGNMENT OF THE J11 PINS WITH THE MEMBRANE TAIL TRACKS AND THE SUBSEQUENT SPEECH CHIP LABEL MISMATCH. HEARTSINE RECORDS INDICATE THE DEVICE HAD PERFORMED TO SPECIFICATION DURING OUT QAT TESTING ON THE (B)(6) 2016, INDICATING THAT THE MEMBRANE TAIL HAD MADE SUFFICIENT CONTACT WITH THE J11 PINS AT THIS TIME. 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 SAM 500P.

    Description of Event or Problem · 0

    DEVICE SERVICE REQUIRED. NO PATIENT INVOLVED.

    Description of Event or Problem · 0

    DEVICE SERVICE REQUIRED. NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565860 HEARTSINE SAMARITAN 500P AND PAD-PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1