BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSINE SAMARITAN 500P AND PAD-PAK

    MDR report key: 7420606 · Received April 11, 2018

    Report

    Report Number
    3004123209-2018-00264
    Event Type
    Malfunction
    Date Received
    April 11, 2018
    Date of Event
    April 1, 2018
    Report Date
    June 12, 2018
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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). H3 OTHER TEXT: DEVICE NOT RETURNED YET.

    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. NO REWORK WAS CONDUCTED. THE SAM 500P PASSED ¿OUT QAT FROM HEARTSINE TECHNOLOGIES ON THE 12TH FEBRUARY 2015. ON VISUAL INSPECTION THE MEMBRANE TAIL WAS FOUND TO HAVE BEEN INCORRECTLY INSTALLED. THIS HAD RESULTED IN THE MISALIGNMENT OF THE PINS WITHIN THE J11 CONNECTOR WITH THE MEMBRANE TAIL TRACKS, CAUSING A SPEECH CHIP LABEL MISMATCH. THIS WOULD EXPLAIN THE ¿WARNING, DEVICE SERVICE REQUIRED¿ PROMPTS REPORTED BY THE CUSTOMER. THE FAULTS COULD NOT BE REPLICATED WITH THE MEMBRANE TAIL CORRECTLY ALIGNED. HEARTSINE RECORDS INDICATE THE DEVICE HAD PERFORMED TO SPECIFICATION DURING OUT QAT TESTING ON THE 12TH FEBRUARY 2015, INDICATING THAT THE MEMBRANE TAIL HAD MADE SUFFICIENT CONTACT WITH THE J11 PINS AT THIS TIME. FURTHERMORE, THE RETURNED PAD-PAK WAS FOUND TO BE SEVERELY DEPLETED. THIS WAS ATTRIBUTED TO THE DEVICE REMAINING IN FAULT MODE AFTER THE 29TH NOVEMBER 2015, FOLLOWING THE FIRST SELF-TEST FAILURE DUE TO THE SPEECH CHIP LABEL MISMATCH. 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 NEW SAM 500P.

    Description of Event or Problem · 0

    DEVICE SERVICE REQUIRED PROMPT HEARD. NO PATIENT INVOLVED.

    Description of Event or Problem · 0

    DEVICE SERVICE REQUIRED PROMPT HEARD. NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263704 HEARTSINE SAMARITAN 500P AND PAD-PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1