BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EARLYVUE VS30 VITAL SIGNS MONITOR

    MDR report key: 13636336 · Received March 1, 2022

    Report

    Report Number
    1218950-2022-00164
    Event Type
    Malfunction
    Date Received
    March 1, 2022
    Date of Event
    February 3, 2022
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    DSJ
    UDI-DI
    00884838091412
    PMA / PMN Number
    K190624
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE DEVICE FELL OFF FROM A ROLL STAND AND BROKE THE LCD AND TOUCHSCREEN. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE EVENT. 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).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE DEVICE FELL OFF FROM A ROLL STAND AND BROKE THE LCD AND TOUCHSCREEN. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1992929 EARLYVUE VS30 VITAL SIGNS MONITOR EARLYVUE VS30 VITAL SIGNS MONITOR DSJ PHILIPS NORTH AMERICA LLC 863380 00884838091412

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown