BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EARLYVUE VS30

    MDR report key: 23953676 · Received January 3, 2026

    Report

    Report Number
    9610816-2026-000007
    Event Type
    Malfunction
    Date Received
    January 3, 2026
    Date of Event
    December 10, 2025
    Report Date
    January 4, 2026
    Manufacturer
    PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH
    Product Code
    DQA
    UDI-DI
    00884838075900
    PMA / PMN Number
    K190624
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1: REPORTER INSTITUTION PHONE NUMBER: (B)(6). E1: REPORTER PHONE NUMBER: (B)(6). THE PHILIPS REMOTE SERVICE ENGINEER (RSE) INTERVIEWED THE CUSTOMER AND SUSPECTED A PNI PUMP FAILURE; THEREFORE, A NEW PNI PUMP WAS ORDERED TO RESOLVE THE ISSUE. THE RSE ALSO DISPATCHED A PHILIPS FIELD SERVICE ENGINEER (FSE) ONSITE TO FURTHER EVALUATE THE UNIT. ONCE ONSITE, THE FSE CONDUCTED AN ELECTRICAL SAFETY TEST AND PATIENT SIMULATION TO VERIFY THAT THE PROBLEM HAS BEEN CORRECTED. THE NECESSARY VERIFICATIONS HAVE BEEN CARRIED OUT TO CERTIFY THE RESTORATION TO THE OPERATING CONDITIONS PRIOR TO THE FAILURE. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED, THE CAUSE OF THE REPORTED PROBLEM WAS CONFIRMED TO BE THE FAULTY PNI PUMP. THE REPORTED PROBLEM WAS CONFIRMED. THE UNIT WAS OPERATIONAL AFTER THE FAULTY PART WAS REPLACED. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED.

    Description of Event or Problem · 0

    IT IS OBSERVED THAT THE PNI PUMP HAS AN IRREGULAR BEHAVIOR AND DOES NOT ACTIVATE CORRECTLY. RANDOMLY, DURING THE MEASUREMENT OF BLOOD PRESSURE, IT FAILS TO OBTAIN CONSTANTS, ACTIVATING THE PUMP REPEATEDLY WITHOUT REGISTERING VALUES. ALSO, ON SOME OCCASIONS, ONCE THE MEASUREMENT PROCESS IS FINISHED, IT DOES NOT RELEASE THE PRESSURE OF THE CUFF. THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14947 EARLYVUE VS30 EARLYVUE VS30 DQA PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH 863359 00884838075900

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown