BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EARLYVUE

    MDR report key: 11019523 · Received December 16, 2020

    Report

    Report Number
    9610816-2020-00456
    Event Type
    Malfunction
    Date Received
    December 16, 2020
    Report Date
    August 19, 2020
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DQA
    UDI-DI
    00884838091412
    PMA / PMN Number
    K190624
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    :THE DEVICE WAS RETURNED TO PHILIPS FOR EVALUATION. DUE TO A CHANGE IN DECONTAMINATION PROCESSES WHICH ALSO INVOLVED A FACILITY CHANGE, THE DEVICE CANNOT BE LOCATED. DUE TO AGE OF THE COMPLAINT, THE CASE WILL BE CLOSED. IF/WHEN THE DEVICE BE LOCATED, EVALUATION OF THE DEVICE WILL BE DOCUMENTED IN THE DEFOA DATABASE UNDER DEFOA-2020-08-34124.THE CUSTOMER WAS SENT A REPLACEMENT DEVICE. REFERENCE MANUFACTURER'S REPORT NUMBER 1218950-2020-04913 PREVIOUSLY SUBMITTED WITH INCORRECT REGISTRATION NUMBER. SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE WAS RETURNED TO PHILIPS BUT CAN NOT BE LOCATED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE PROBLEM OF SPEAKER MALFUNCTION. THE DEVICE WAS NOT IN USE ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1483947 EARLYVUE MULTI-PARAMETER PATIENT MONITOR DQA PHILIPS MEDICAL SYSTEMS 863380 00884838091412

    Patients

    Seq Age Sex Outcome Treatment
    1