BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EARLYVUE VS30 VITAL SIGNS MONITOR

    MDR report key: 12478516 · Received September 15, 2021

    Report

    Report Number
    1218950-2021-10925
    Event Type
    Malfunction
    Date Received
    September 15, 2021
    Date of Event
    September 2, 2021
    Report Date
    September 15, 2021
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    DSJ
    UDI-DI
    00884838091412
    PMA / PMN Number
    K190624
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TROUBLESHOOTING PERFORMED ON THE DEVICE WAS COMPLETE BY THE CUSTOMER PRIOR TO THEM CONTACTING PHILIPS. AT THE TIME OF CONTACT WITH PHILIPS, NO ADDITIONAL DEVICE EVALUATION WAS PERFORMED AS THE CUSTOMER REQUESTED REPLACEMENT OF THE DEVICE'S SPO2 BOARD ASSEMBLY. THE FOLLOWING PART WAS SENT TO THE CUSTOMER FOR REPLACEMENT: 453564792521,CHL-VS PHILIPS SPO2 BD ASSY - FS. THE DEVICE REMAINS AT THE CUSTOMER SITE.

    Description of Event or Problem · 1

    PER THE CUSTOMER, "AN SPO2 CARD OFFSET VALUES WITH THE SIMULATOR". PATIENT INVOLVEMENT IS UNKNOWN. THE EARLYVUE VS30 VITALS MONITOR (MODEL NUMBER 863359) IS SUBSTANTIALLY SIMILAR TO THE EARLYVUE VS30 VITALS MONITOR (MODEL NUMBER 863380) AND WILL BE REPORTED IN THE UNITED STATES UNDER DEVICE MODEL NUMBER 863380 (CFN/FEI # 1218950; 510K K190624).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1375316 EARLYVUE VS30 VITAL SIGNS MONITOR EARLYVUE VS30 VITAL SIGNS MONITOR DSJ PHILIPS NORTH AMERICA LLC 863380 00884838091412

    Patients

    Seq Age Sex Outcome Treatment
    1