BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 8874656 · Received August 8, 2019

    Report

    Report Number
    2031642-2019-05630
    Event Type
    Malfunction
    Date Received
    August 8, 2019
    Report Date
    February 8, 2018
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: (B)(6) 2018. DATE OF REPORT: 08AUG2019. NO DEVICE EVALUATION WAS CONDUCTED AS THE REPORTED PROBLEM WAS RESOLVED OVER TECHNICAL SUPPORT (TS) CALL. TS CONFIRMED THE REPORTED ISSUE. TS RECOMMENDED THAT IN THIS INSTANCE TO USE THE HIGHEST READING IN THE SERVICE MANUAL. TS INFORMED THAT CUSTOMER THAT THE BAROMETRIC CHART HAS BEEN EXPANDED WITH THE LATEST SERVICE MANUAL REV J. NO PARTS WERE REPLACED. 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

    CUSTOMER REPORTS FAILED PERFORMANCE VERIFICATION TESTING 5 (PVT TEST 5).THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS DISCOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670070 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60

    Patients

    Seq Age Sex Outcome Treatment
    1