BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSPHERE

    MDR report key: 24011497 · Received January 8, 2026

    Report

    Report Number
    2015691-2026-10271
    Event Type
    Malfunction
    Date Received
    January 8, 2026
    Date of Event
    December 12, 2025
    Report Date
    March 5, 2026
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DQK
    UDI-DI
    00690103197006
    PMA / PMN Number
    K243781
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FDA PRODUCT CODES: DQE CATHETER, OXIMETER, FIBEROPTIC. QAQ ADJUNCTIVE PREDICTIVE CARDIOVASCULAR INDICATOR. MUD OXIMETER, TISSUE SATURATION. DXN SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE. DSB PLETHYSMOGRAPH, IMPEDANCE. QMS ADJUNCTIVE OPEN LOOP FLUID THERAPY RECOMMENDER. FLL THERMOMETER, ELECTRONIC, CLINICAL. OLW INDEX-GENERATING ELECTROENCEPHALOGRAPH SOFTWARE. THE DEVICE EVALUATION IS ANTICIPATED. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WHEN THE INVESTIGATION IS COMPLETED. THE DEVICE HISTORY RECORD REVIEW HAS NOT BEEN COMPLETED. THE DEVICE HISTORY RECORD WAS REVIEWED; NO RELATED NON-CONFORMANCES WERE FOUND. NO ESCALATION IS REQUIRED AT THIS TIME. 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 Manufacturer Narrative · 0

    A PRODUCT EVALUATION WAS COMPLETED ON THE RETURNED HEMOSPHERE 1 MONITOR. THE REPORTED ISSUE COULD NOT BE CONFIRMED. THE EVALUATION LAB WAS ABLE TO OBTAIN NORMAL CO READING (~ 7.5 L/MIN) ON MODULE SLOTS 1 AND 2 USING A SWAN GANZ MODULE AND SIMULATOR. THE CO READING REMAINED STABLE WITHOUT ERROR FOR 30 MINUTES ON EACH MODULE SLOT. BASED ON THE REPORTED ISSUE THERE IS NOT SUFFICIENT EVIDENCE TO SUGGEST THAT THE DEVICE RELATED ISSUE RESULTED FROM ANY OF THE SPECIFIED FACTORS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, BEFORE USE, THE HEMOSPHERE 1 MONITOR WAS NOT GIVING CORRECT CO NUMBERS. THE CLINICIAN CHANGED CABLES WITHOUT RESOLVE. A NEW MONITOR WORKED AS EXPECTED. IT WAS CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383158 HEMOSPHERE COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK EDWARDS LIFESCIENCES HEM1 13824913 00690103197006

    Patients

    Seq Age Sex Outcome Treatment
    1