BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORESIGHT IQ

    MDR report key: 24782754 · Received April 3, 2026

    Report

    Report Number
    2015691-2026-13831
    Event Type
    Malfunction
    Date Received
    April 3, 2026
    Date of Event
    March 12, 2026
    Report Date
    April 27, 2026
    Manufacturer
    EDWARDS LIFESCIENCES IRVINE
    Product Code
    DQE
    UDI-DI
    00690103219616
    PMA / PMN Number
    K242451
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PER REVIEW OF THE IMAGES PROVIDED BY THE CUSTOMER, IT'S CONFIRMED IMAGE 1 SHOWS HEMOSPHERE ALTA MONITOR DISPLAYING FORESIGHT THB AS 6.8G/DL AND IMAGE 2 SHOWS ARTERIAL BLOOD GAS RESULTS WITH HB CPB AS 8.5G/DL. THE DEVICE WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE UNIT, IT IS NOT POSSIBLE TO DETERMINE IF SOME DAMAGE OR DEFECT EXISTED ON THE UNIT THAT COULD HAVE CONTRIBUTED TO THE EVENT. IT IS NOT KNOWN IF SOME PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. A DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE COMPLETED AS THE LOT NUMBER WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL FDA PRODUCT CODES INCLUDE: DSB, PLETHYSMOGRAPH, IMPEDANCE. DXN, SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE. FLL, CONTINUOUS MEASUREMENT THERMOMETER. MUD, OXIMETER, TISSUE SATURATION. QAQ, ADJUNCTIVE PREDICTIVE CARDIOVASCULAR INDICATOR. QEM, CEREBRAL OXIMETER. QMS, ADJUNCTIVE OPEN LOOP FLUID THERAPY RECOMMENDER. QNL, MEDIUM-TERM ADJUNCTIVE PREDICTIVE CARDIOVASCULAR INDICATOR. THE DEVICE EVALUATION IS ANTICIPATED. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WHEN THE INVESTIGATION IS 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE FORESIGHT SENSOR THE TOTAL HEMOGLOBIN WAS OFF BY MORE THAN 1 G. THERE WAS NO ALLEGATION OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93583 FORESIGHT IQ CATHETER, OXIMETER, FIBER-OPTIC DQE EDWARDS LIFESCIENCES IRVINE FSESLIQ NI 00690103219616

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown