BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 8621415 · Received May 17, 2019

    Report

    Report Number
    2031642-2019-03048
    Event Type
    Malfunction
    Date Received
    May 17, 2019
    Report Date
    April 30, 2019
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    UDI-DI
    00884838020054
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF REPORT: 11JUN2019. DATE REC'D BY MFR:04JUN2019. THE FIELD SERVICE ENGINEER WENT ON-SITE AND FOUND THAT THE VENTILATOR WAS IN USE AND THE TOUCHSCREEN WAS WORKING. NO FAULT WAS FOUND WITH THE VENTILATOR SO THERE WAS NO SERVICE WORK PERFORMED. NO PARTS WERE REPLACED SO NO PARTS ARE EXPECTED TO BE RETURNED FOR FAILURE INVESTIGATION. 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: 17MAY2019. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE VENTILATOR'S TOUCHSCREEN WAS FAULTY. THERE WAS NO PATIENT OR USER INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415278 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1