BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 9808913 · Received March 9, 2020

    Report

    Report Number
    2031642-2020-00838
    Event Type
    Malfunction
    Date Received
    March 9, 2020
    Report Date
    February 20, 2020
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    G4: 06APR2020. B4: 07APR2020. THE MANUFACTURER¿S INTERNATIONAL SERVICE TECHNICIAN EVALUATED THE VENTILATOR AND CONFIRMED THAT THE OPERATIONAL SOUND WAS LOUD AND NOISE WAS GENERATED BUT IT WAS NOT COMING FROM THE BLOWER MOTOR AND NO ISSUES WITH THE BLOWER WERE IDENTIFIED. THE SERVICE TECHNICIAN COULD NOT CONFIRM NOR DUPLICATE THE REPORTED ISSUE THAT CHECKING OPERATIONS SOMETIMES FAILED TO GO FORWARD TO THE NEXT STEP. THERE WERE NO DIAGNOSTIC CODES RECORDED IN THE SIGNIFICANT EVENT LOG AND NO FAILURES WERE IDENTIFIED DURING TESTING. THE SERVICE TECHNICIAN REPOSITIONED THE VIBRATION DAMPENING RING TO ADDRESS THE NOISE. THE VENTILATOR SUCCESSFULLY PASSED FUNCTIONALITY TESTING AFTER THE REPAIR WAS COMPLETED. NO PARTS WERE REPLACED; THEREFORE, THE ROOT CAUSE AT THE COMPONENT LEVEL COULD NOT BE DETERMINED. 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) 2020. REPORT DATE: 09MAR2020.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NOISE OCCURRED WHEN THE EXHALATION PORT WAS CHECKED AND DURING TESTING. IT WAS ALSO REPORTED THAT SOMETIMES THE UNIT FAILED TO GO FORWARD TO THE NEXT STEP DURING OPERATION. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267976 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60

    Patients

    Seq Age Sex Outcome Treatment
    1