BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 8965272 · Received September 5, 2019

    Report

    Report Number
    2031642-2019-08089
    Event Type
    Malfunction
    Date Received
    September 5, 2019
    Report Date
    August 9, 2018
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MFR REPORT #2031642-2019-08089 IS A DUPLICATE OF AN EVENT PREVIOUSLY REPORTED UNDER MFR REPORT # 2031642-2019-07898. ANY ADDITIONAL INFORMATION WILL BE SUBMITTED UNDER THE INITIALLY REPORTED MFR #2031642-2019-07898. 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) 2018. DATE OF REPORT: 09/05/2019. THE MANUFACTURER¿S FIELD SERVICE ENGINEER (FSE) REPLACED THE DEFECTIVE FRONT BEZEL TO ADDRESS THE REPORTED PROBLEM. THE UNIT SUCCESSFULLY PASSED THE REQUIRED PERFORMANCE VERIFICATION TEST. FAILURE ANALYSIS OF THE RETURNED PART INDICATES: ROOT CAUSE: CONTAMINATION BUILDUPS WERE FOUND ON THE ROTARY ADJUSTMENT ASSEMBLY (NAV-RING) MATRIX OF THE NEW NAV-RING PRODUCTION PROCESS THAT CAUSED THE NAV-RING NOT TO FUNCTION. ROOT CAUSE: CONTAMINATION BUILDUPS WERE FOUND ON THE ROTARY ADJUSTMENT ASSEMBLY (NAV-RING) MATRIX OF THE NEW NAV-RING PRODUCTION PROCESS THAT CAUSED THE NAV-RING NOT TO FUNCTION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY CANNOT ADJUST THE DISPLAY OR ANY PARAMETERS WITH THE NAV-RING. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761448 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60

    Patients

    Seq Age Sex Outcome Treatment
    1