BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 8962931 · Received September 4, 2019

    Report

    Report Number
    2031642-2019-08057
    Event Type
    Malfunction
    Date Received
    September 4, 2019
    Report Date
    August 6, 2018
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: (B)(6) 2018. DATE OF REPORT: 04SEP2019. THE MANUFACTURER'S TECHNICAL SERVICES (TS) CONFIRMED THE REPORTED ISSUE. PROVIDED P/N 1100822. ALSO ADVISED CUSTOMER TO EXPECT ILLUMINATION TO CONTINUE TO DIMINISH DUE TO AGE OF LCD; HALF LIFE OF COMPONENT IS 10,000 HOURS. RECOMMEND CUSTOMER TO PREPARE FOR LCD FAILURE IN THE NEXT YEAR. THE CUSTOMER ORDERED THE UI ASSEMBLY TO MAKE NECESSARY REPAIRS. THIS MDR HAS BEEN REASSESSED AS REPORTABLE AFTER A REQUEST FROM THE FDA ON MARCH 1, 2019 TO REVIEW COMPLAINTS FROM 29 NOV 2017 TO 29 NOV 2018. AS THIS HAS BEEN REASSESSED, IT WILL APPEAR TO BE A LATE MDR. 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 · 1

    THE CUSTOMER REPORTED THE VENTILATOR HAD A DIM DISPLAY. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757194 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60

    Patients

    Seq Age Sex Outcome Treatment
    1