BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN SAPPHIRE PUMP

    MDR report key: 22724610 · Received August 6, 2025

    Report

    Report Number
    3010293992-2025-00051
    Event Type
    Malfunction
    Date Received
    August 6, 2025
    Date of Event
    July 24, 2025
    Report Date
    September 14, 2025
    Manufacturer
    EITAN MEDICAL LTD.
    Product Code
    FRN
    PMA / PMN Number
    K161667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EITAN MEDICAL REQUESTED ADDITIONAL INFORMATION, THE PUMP AND THE EVENT LOG FOR INVESTIGATION. TO DATE, NONE HAVE BEEN RECEIVED. WHEN RECEIVED, THE INVESTIGATION FINDINGS WILL BE DETAILED IN A FOLLOW-UP REPORT. THIS REPORTED EVENT OCCURRED OUTSIDE OF THE US ON A DEVICE THAT IS SIMILAR TO THE ONE MARKETED IN THE US AND FOR WHICH THERE IS NO DATA IN GUDID. DEVICE'S PREMARKET SUBMISSION NUMBER: K161667.

    Additional Manufacturer Narrative · 0

    EITAN MEDICAL HAS CONDUCTED MULTIPLE ATTEMPTS TO RECEIVE THE EVENT LOG OF PUMP, AS WELL AS THE PUMP ITSELF, FOR INVESTIGATION. HOWEVER, NEITHER WAS PROVIDED BY THE CUSTOMER. AS A RESULT, A COMPREHENSIVE INVESTIGATION OF THIS EVENT COULD NOT BE CONDUCTED. IF THE EVENT LOG AND/OR THE PUMP ARE PROVIDED BY THE CUSTOMER, AN INVESTIGATION WILL BE CONDUCTED, AND THE INVESTIGATION'S FINDINGS WILL BE PRESENTED IN A FOLLOW UP REPORT. THIS REPORTED EVENT OCCURRED OUTSIDE OF THE US ON A DEVICE THAT IS SIMILAR TO THE ONE MARKETED IN THE US AND FOR WHICH THERE IS NO DATA IN GUDID. DEVICE'S PREMARKET SUBMISSION NUMBER: K161667.

    Description of Event or Problem · 0

    THIS COMPLAINT WAS REPORTED BY A CUSTOMER FROM FRANCE. A DELIVERY ISSUE WAS REPORTED. NO HUMAN HARM OR MEDICAL INTERVENTION WAS REPORTED.

    Description of Event or Problem · 0

    THIS COMPLAINT WAS REPORTED BY A CUSTOMER FROM FRANCE. A DELIVERY ISSUE WAS REPORTED. NO HUMAN HARM OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1555912 UNKNOWN SAPPHIRE PUMP INFUSION PUMP FRN EITAN MEDICAL LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown