BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EARLYVUE VS30

    MDR report key: 24396932 · Received February 19, 2026

    Report

    Report Number
    9610816-2026-100331
    Event Type
    Malfunction
    Date Received
    February 19, 2026
    Date of Event
    January 29, 2026
    Report Date
    February 19, 2026
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
    Product Code
    DQA
    UDI-DI
    00884838091412
    PMA / PMN Number
    K190624
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REMOTE SERVICE ENGINEER (RSE) WORKED WITH THE CUSTOMER BIOMED FOR TROUBLESHOOTING SUPPORT. BASED ON THE RESULTS OF THE DISCUSSION WITH THE CUSTOMER IT WAS IDENTIFIED THAT THE EARLYVUE VS30 WAS NOT IN CLINICAL USE AND SHOWING HIGH NON-INVASIVE BLOOD PRESSURE READINGS. CALIBRATION WAS ATTEMPTED BUT THE READINGS REMAINED INACCURATE AT 142/120 MMHG. THE ENGINEER ADVISED THAT A FAILED CALIBRATION INDICATED A DEFECTIVE PUMP, REQUIRING A REPLACEMENT. THE CUSTOMER WAS PROVIDED WITH THE PART NUMBER. BASED ON THE RESULTS OF THE ANALYSIS, IT WAS DETERMINED THAT THE PRODUCT HAS MALFUNCTIONED AND THE MOST LIKELY CAUSED OF THE REPORTED PROBLEM WAS A FAULTY NIBP MODULE PUMP. THE ISSUE WAS RESOLVED AFTER THE DEFECTIVE PART WAS REPLACED WITH A NEW PUMP. THE INVESTIGATION CONCLUDED THAT NO FURTHER ACTION WAS REQUIRED, AND THE COMPLAINT FILE WOULD BE REASSESSED IF ADDITIONAL INVERMINATION WAS RECEIVED.

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT ON AN EARLYVUE VS30 INDICATING THAT THE UNIT WAS MEASURING INCORRECT NIBP. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF EVENT; THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455817 EARLYVUE VS30 OXIMETER DQA PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH EARLYVUE VS30 VITALS MONITOR 00884838091412

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown