BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSPHERE FORESIGHT MODULE

    MDR report key: 24463271 · Received February 26, 2026

    Report

    Report Number
    2015691-2026-11582
    Event Type
    Malfunction
    Date Received
    February 26, 2026
    Date of Event
    February 5, 2026
    Report Date
    May 6, 2026
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    MUD
    UDI-DI
    00690103208573
    PMA / PMN Number
    K180003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE EVALUATION IS ANTICIPATED. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WHEN THE INVESTIGATION IS COMPLETED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS A PART OF THE MONTHLY REVIEW. ADDITIONAL D2B DEVICE PRODUCT CODES: DQK, DQE, QAQ, DXN, DSB, QMS, FLL. ADDITIONAL G4. 510K: K213682.

    Additional Manufacturer Narrative · 0

    ONE FORESIGHT MODULE WAS RETURNED FOR EVALUATION. THE REPORTED ISSUE WAS CONFIRMED. THERE WAS NO FAULT ERRORS DISPLAYED WHEN THE DEVICE CONNECTED TO A KNOWN WORKING HEM1. CHANNEL 1 AND 2 DISPLAYED 65 PERCENT STO2 (PLUS OR MINUS 5 PERCENT) WITH SIMULATORS CONNECTED THE INTERNAL HARDWARE AND CONNECTIVITY ARE PERFORMING AS INTENDED. MANIPULATING THE CABLES AT NO POINT INFLUENCED THE READINGS. ALTHOUGH THERE IS NO PHYSICAL DAMAGE TO DEVICE, THERE IS A LABEL DISCREPANCY IDENTIFYING SENSOR CABLES CHANNEL 1 AND CHANNEL 2. THE FLAG LABEL AND SENSOR CONNECTOR LABEL FOR SENSOR CABLE 1 WERE PLACED ON SENSOR CABLE 2 AND VICE VERSA. THE LABEL PLACEMENT DID NOT AFFECT UNIT PERFORMANCE BUT THERE IS POTENTIAL FOR CONFUSION BY USER REGARDING WHICH VALUES BELONG TO WHICH SENSOR. AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. CURRENT PRELIMINARY CAUSE SUGGEST THAT THE LABELING SWAP ISSUE ORIGINATED FROM THE MANUFACTURER.

    Description of Event or Problem · 0

    IT WAS REPORTED BEFORE USE OF THIS FORESIGHT OXIMETER CABLE, THE CONNECTED A2 APPEARED AS A1 ON MONITOR, WITH NO SENSOR CONNECTED TO A1. ISSUE WAS UNABLE TO BE RESOLVED. THERE WAS NO PATIENT INJURY. THE DEVICE WILL BE AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283336 HEMOSPHERE FORESIGHT MODULE OXIMETER, TISSUE SATURATION MUD EDWARDS LIFESCIENCES HEMFSM10 21129860 00690103208573

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown