BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EARLYVUE VS30

    MDR report key: 24586796 · Received March 12, 2026

    Report

    Report Number
    9610816-2026-100498
    Event Type
    Malfunction
    Date Received
    March 12, 2026
    Date of Event
    February 13, 2026
    Report Date
    March 12, 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
    MD, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS WAS PERFORMED BY PHILIPS REMOTE SERVICE PERSONNEL WHICH INCLUDED TALKING TO THE CUSTOMER WHO CONFIRMED AFTER TROUBLESHOOTING DONE, THAT THE DEVICE IS NOT READING CORRECTLY EVEN THE PUMP IS PUMPING REPEATEDLY. THE BLOOD PRESSURE (NBP) PUMP NEEDS REPLACEMENT. THE RESULTS OF THE ANALYSIS WERE THE REMOTE SUPPORT ENGINEER (RSE) CONFIRMED THE NMP PUMP NEEDS REPLACEMENT AND ARRANGE FOR A REPLACEMENT PART TO BE SENT TO THE CUSTOMER. BASED ON THE RESULTS OF THE ANALYSIS, IT WAS DETERMINED THAT THE PRODUCT HAS MALFUNCTIONED AND THE MOST LIKELY CAUSE OF THE REPORTED PROBLEM WAS A DEFECTIVE NBP PUMP. THE ISSUE WAS RESOLVED BY PROVIDING THE CUSTOMER A REPLACEMENT PART. THE CUSTOMER WILL DO THE REPAIR ONSITE. SERVICE HISTORY REVIEW CONFIRM THE PROBLEM HAS NOT BEEN REPORTED AGAIN FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE DEVICE DOES NOT READ BLOOD PRESSURE ACCURATELY EVEN THE PUMP CONTINUES TO PUMP REPEATEDLY. THE DEVICE WAS IN CLINICAL USE. THERE WAS NO REPORT OF PATIENT OR USER HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647197 EARLYVUE VS30 EARLYVUE VS30 DQA PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH EARLYVUE VS30 VITALS MONITOR 00884838091412

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown