BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 8958405 · Received September 3, 2019

    Report

    Report Number
    2031642-2019-07898
    Event Type
    Malfunction
    Date Received
    September 3, 2019
    Report Date
    August 9, 2018
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    UDI-DI
    00884838020054
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS NO PATIENT INVOLVEMENT. DEVICE RETURNED TO MANUFACTURE: YES DATE RETURNED TO MANUF. 10/12/2018. REPORT SOURCES: USER FACILITY. FAILURE ANALYSIS OF THE RETURNED PART INDICATES A ROOT CAUSE: CONTAMINATION BUILDUPS WERE FOUND ON THE ROTARY ADJUSTMENT ASSEMBLY (NAV-RING) MATRIX OF THE NEW NAV-RING PRODUCTION PROCESS THAT CAUSED THE NAV-RING NOT TO FUNCTION. 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) 2018. DATE OF REPORT: 03SEP2019. 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. THE CUSTOMER REPORTED THAT THEY CANNOT ADJUST THE DISPLAY OR ANY PARAMETERS WITH THE NAV-RING. THE MANUFACTURER'S FIELD SERVICE ENGINEER CONFIRMED THE REPORTED NAV-RING ISSUE. THE MANUFACTURER¿S FIELD SERVICE ENGINEER (FSE) REPLACED THE DEFECTIVE FRONT BEZEL TO ADDRESS THE REPORTED PROBLEM.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY CANNOT ADJUST THE DISPLAY OR ANY PARAMETERS WITH THE NAV-RING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750757 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1