BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 8786146 · Received July 12, 2019

    Report

    Report Number
    2031642-2019-04501
    Event Type
    Malfunction
    Date Received
    July 12, 2019
    Report Date
    June 28, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DATE REC¿D BY MFR: 25SEP2019 . DATE OF REPORT: 26SEP2019. THE TOUCHSCREEN ASSEMBLY WAS RETURNED TO FAILURE INVESTIGATION (FI) FOR EVALUATION. VISUAL INSPECTION OF THE TOUCH SCREEN ASSEMBLY REVEALED NO EVIDENCE OF DAMAGE OR CONTAMINATION. RESISTANCE MEASUREMENTS WILL BE PERFORMED ON THE RETURNED TOUCHSCREEN ASSEMBLY. THE TOUCHSCREEN MEASURED RESISTANCE AND RESISTANCE RATIO ARE OUT OF SPECIFICATION. NO FURTHER FI IS REQUIRED. THE MANUFACTURER¿S FIELD SERVICE ENGINEER (FSE) REPLACED THE DEFECTIVE TOUCHSCREEN TO ADDRESS THE REPORTED PROBLEM. THE UNIT SUCCESSFULLY PASSED THE REQUIRED PERFORMANCE VERIFICATION TEST. 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

    THE CUSTOMER REPORTED TOUCHSCREEN FAILURE. THERE WAS NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: (B)(6) 2019. DATE OF REPORT: 12JULY2019. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TOUCHSCREEN FAILURE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580850 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1