BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 8663180 · Received June 3, 2019

    Report

    Report Number
    2031642-2019-03406
    Event Type
    Malfunction
    Date Received
    June 3, 2019
    Report Date
    April 24, 2019
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    UDI-DI
    00884838033832
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DATE RECEIVED BY MANUFACTURER: 12JUN2019. DATE OF REPORT: 13JUN2019. THE MANUFACTURER'S INTERNATIONAL SERVICE TECHNICIAN CONFIRMED THE REPORTED PROBLEM. THE IINTERNATIONAL SERVICE TECHNICIAN REPLACED THE POWER SWITCH OVERLAY TO ADDRESS THE LED ISSUE, AND ALSO REPLACED THE OXYGEN INLET FILTER, INLET AIR FILTER, AND COOLING FAN IN ACCORDANCE WITH THE MAINTENANCE PROCEDURE. THE UNIT PASSED ALL PERFORMANCE TESTS AFTER REPAIRS. NO PARTS HAVE BEEN RETURNED FOR FAILURE INVESTIGATION AND THE ROOT CAUSE CANNOT 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) 2019. DATE OF REPORT: 01JUNE2019. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE LED INDICATOR WAS FAULTY. THE ISSUE WAS NOT DURING CLINICAL USE, AND THERE WAS NO PATIENT OR USER INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455344 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60 00884838033832

    Patients

    Seq Age Sex Outcome Treatment
    1