BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EARLYVUE

    MDR report key: 10448796 · Received August 25, 2020

    Report

    Report Number
    1218950-2020-04913
    Event Type
    Malfunction
    Date Received
    August 25, 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 · 0

    CONCOMITANT MEDICAL PRODUCTS: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. 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. H3 OTHER TEXT : THE DEVICE WAS RETURNED TO PHILIPS BUT CAN NOT BE LOCATED.

    Additional Manufacturer Narrative · 0

    H10: THIS REPORT WAS SUBMITTED WITH AN INCORRECT REGISTRATION NUMBER. PLEASE REFERENCE MANUFACTURER'S REPORT NUMBER 9610816-2020-00456 AS THE CORRECTED RECORD. 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.

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    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
    916671 EARLYVUE MULTI-PARAMETER PATIENT MONITOR DQA PHILIPS MEDICAL SYSTEMS 863380 00884838091412

    Patients

    Seq Age Sex Outcome Treatment
    1