BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 8785453 · Received July 12, 2019

    Report

    Report Number
    2031642-2019-04490
    Event Type
    Malfunction
    Date Received
    July 12, 2019
    Report Date
    June 27, 2019
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    UDI-DI
    00884838020054
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    DATE REC'D FROM MFR: 14OCT2019. THE TOUCHSCREEN MEASURED RESISTANCE AND RESISTANCE RATIO ARE OUT OF SPECIFICATION. NO FURTHER FI IS REQUIRED. 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

    Description of Event or Problem · 0

    CUSTOMER CONTACTED TECHNICAL SUPPORT (TS) STATING THAT UNIT AFTER NUMEROUS TOUCH SCREEN CALIBRATIONS THAT THE TOP LEFT OF THE SCREEN IS STILL OFF TO THE TOUCH. THE CUSTOMER REPORTED THERE WAS NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: (B)(6) 2019. DATE OF REPORT: 11JUL2019. MANUFACTURER'S FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNIT AND CONFIRMED THE REPORTED ISSUE AND REPLACED THE UNIT'S TOUCHSCREEN AND RAN CALIBRATION TO RESOLVE THE REPORTED ISSUE. UNIT WAS TESTED AND PASSED. UNIT IS BACK IN SERVICE.

    Description of Event or Problem · 1

    CUSTOMER CONTACTED TECHNICAL SUPPORT (TS) STATING THAT UNIT AFTER NUMEROUS TOUCH SCREEN CALIBRATIONS THAT THE TOP LEFT OF THE SCREEN IS STILL OFF TO THE TOUCH. THE CUSTOMER REPORTED THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580985 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1