BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EARLYVUE VS30 VITALS MONITOR

    MDR report key: 12245366 · Received July 29, 2021

    Report

    Report Number
    1218950-2021-10748
    Event Type
    Malfunction
    Date Received
    July 29, 2021
    Date of Event
    July 15, 2021
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    UDI-DI
    00884838091412
    PMA / PMN Number
    190624
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS CREATED WITH REFERENCE TO MFG REPORT WITH CORRECTED INFORMATION TO UPDATE THE MANUFACTURING SITE.

    Additional Manufacturer Narrative · 0

    IT IS NOT KNOWN HOW THE DEVICE FELL AND NO ADDITIONAL INFORMATION IF THE DEVICE WAS ATTACHED TO A ROLL STAND OR WALL MOUNT. THEREFORE, WE ARE CONSIDERING THIS TO BE A MALFUNCTION OF CAUSE UNKNOWN. TO RESOLVE THE SCREEN DAMAGED, THE BRT REPLACED THE FRONT PANEL ASSEMBLY, LCD ASSEMBLY, AND LCD METAL FRAME ASSEMBLY. THE ABSENCE OF FURTHER CALLS SUPPORTS THAT THE REPORTED PROBLEM WAS RESOLVED. THE DEVICE REMAINS IN USE AT THE CUSTOMER'S FACILITY. NO FURTHER ACTION OR INVESTIGATION IS WARRANTED BASED ON THE AVAILABLE INFORMATION AT THE TIME OF COMPLAINT CLOSURE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT AFTER A FALL THE SCREEN IS DAMAGED. PATIENT INVOLVEMENT IS UNKNOWN. NO ADVERSE EVENT INVOLVING A PATIENT OR USER WAS REPORTED BY THE CUSTOMER.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT AFTER A FALL THE SCREEN IS DAMAGED. PATIENT INVOLVEMENT IS UNKNOWN. NO ADVERSE EVENT INVOLVING A PATIENT OR USER WAS REPORTED BY THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SCREEN IS BROKEN FURTHER TO A FALL. THE DEVICE WAS NOT IN CLINICAL USE AT THE TIME THE REPORTED ISSUE WAS DISCOVERED. 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
    1145894 EARLYVUE VS30 VITALS MONITOR EARLYVUE VS30 VITALS MONITOR MHX PHILIPS MEDICAL SYSTEMS 863380 00884838091412

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown