BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART PRESSURE CONTROLLER

    MDR report key: 24080776 · Received January 15, 2026

    Report

    Report Number
    2015691-2026-10425
    Event Type
    Malfunction
    Date Received
    January 15, 2026
    Date of Event
    December 23, 2025
    Report Date
    February 24, 2026
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DQK
    UDI-DI
    00690103219395
    PMA / PMN Number
    K243781
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL PRODUCT CODES INCLUDE: DQE, CATHETER, OXIMETER, FIBER-OPTIC. QAQ, ADJUNCTIVE PREDICTIVE CARDIOVASCULAR INDICATOR. MUD, OXIMETER, TISSUE SATURATION. DXN, SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE. DSB, PLETHYSMOGRAPH, IMPEDANCE. FLL, CONTINUOUS MEASUREMENT THERMOMETER. QMS, ADJUNCTIVE OPEN LOOP FLUID THERAPY RECOMMENDER. OLW, INDEX-GENERATING ELECTROENCEPHALOGRAPH SOFTWARE. THE DEVICE EVALUATION IS ANTICIPATED. HOWEVER, THE COMPLAINT CANNOT BE CONFIRMED WITHOUT THE COMPLETION OF A PRODUCT EVALUATION. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WHEN THE INVESTIGATION IS COMPLETED. THE DEVICE HISTORY RECORD REVIEW WAS NOT COMPLETED AS THE SERIAL NUMBER WAS NOT PROVIDED. 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

    MULTIPLE ATTEMPTS WERE MADE TO SECURE THE RETURN OF THE DEVICE AS WELL AS DATA LOGS. HOWEVER THE DEVICE WAS NOT SENT BACK FOR EVALUATION. WITHOUT 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. THE DEVICE HISTORY RECORD REVIEW WAS NOT COMPLETED AS THE SERIAL NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 0

    AS REPORTED DURING USE IN A HEMOSPHERE STREAM TMR THE SMART PRESSURE CONTROLLER WAS NOT CORRELATING WITH THE BLOOD PRESSURE CUFF VALUES. NO ADDITIONAL INFORMATION WAS AVAILABLE. THERE WAS NO PATIENT INJURY. IT IS UNKNOWN IF THE DEVICE WILL BE AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148977 SMART PRESSURE CONTROLLER COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK EDWARDS LIFESCIENCES PC1Q 00690103219395

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown