BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 10334198 · Received July 28, 2020

    Report

    Report Number
    2031642-2020-02530
    Event Type
    Malfunction
    Date Received
    July 28, 2020
    Report Date
    June 30, 2020
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    QA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    G4: 04NOV2020; B4: 04NOV2020. THE DEVICE WAS NOT IN CLINICAL USE AT THE TIME THE ISSUE WAS DISCOVERED. THERE WAS NO PATIENT OR USER HARM REPORTED. THE DEVICE WAS EVALUATED BY THE CUSTOMER'S HOSPITAL TEAM, WHO CONFIRMED AND DUPLICATED THE REPORTED PROBLEM. THE HOSPITAL TEAM REPLACED THE USER INTERFACE BOARD BASED ON THE RECOMMENDATIONS OF THE INTERNATIONAL PHILIPS REMOTE FIELD SERVICE ENGINEER (RFE). THE DEVICE WAS CONFIRMED TO HAVE BEEN REPAIRED. NO OTHER ABNORMALITIES WERE NOTED. 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) 2020. DATE OF REPORT: 28JUL2020.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE MACHINE CANNOT SWITCH OFF. IT IS UNKNOWN IF THE DEVICE WAS IN CLINICAL USE DURING THE TIME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794947 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60

    Patients

    Seq Age Sex Outcome Treatment
    1