BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 8805120 · Received July 18, 2019

    Report

    Report Number
    2031642-2019-04804
    Event Type
    Malfunction
    Date Received
    July 18, 2019
    Report Date
    June 26, 2019
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DATE RECEIVED BY MANUFACTURER: 12OCT2019. DATE OF REPORT: 16OCT2019. THE GAS DELIVERY SYSTEM ASSEMBLY WAS TESTED AND NO FAILURES WERE IDENTIFIED. 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 · 0

    DATE RECEIVED BY MFR: 5AUG2019. THE MANUFACTURER'S FIELD SERVICE ENGINEER (FSE) CONFIRMED THE REPORTED PROBLEM. THE FSE REPLACED THE FLOW SENSOR ASSEMBLY TO RESOLVE THE ISSUE. 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: 18JUL2019.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OXYGEN CONCENTRATION OUT OF SPECIFICATION. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599308 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60

    Patients

    Seq Age Sex Outcome Treatment
    1