BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 8380693 · Received February 28, 2019

    Report

    Report Number
    2031642-2019-01198
    Event Type
    Malfunction
    Date Received
    February 28, 2019
    Report Date
    February 6, 2019
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    UDI-DI
    00884838020054
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF REPORT: 29MAY2019. DATE REC¿D BY MFR: 21MAY2019. THE MANUFACTURER¿S INTERNATIONAL SERVICE TECHNICIAN CONFIRMED THE REPORTED TOUCHSCREEN ISSUE. THE MANUFACTURER¿S INTERNATIONAL SERVICE TECHNICIAN REPLACED THE TOUCHSCREEN TO ADDRESS THE REPORTED PROBLEM. THE UNIT WAS CHECKED OVERALL, RUN IN TESTED, CLEANED AND FUNCTIONALLY TESTED AND NO ABNORMALITY WAS CONFIRMED. 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

    DATE OF EVENT: (B)(6) 2019. DATE OF REPORT: 28FEB2019. INTERNATIONAL UDI # (B)(4). REPORTER: NO PHONE NUMBER PROVIDED. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE REACTION OF THE TOUCH PANEL HAD BEEN EXTREMELY BAD COMPARED TO OTHER V60'S SINCE THE UNIT WAS PURCHASED. NO PATIENT OR USER HARM WAS REPORTED. EVENT DATE NOT SPECIFIED; ESTIMATE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170117 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1