BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-60

    MDR report key: 4184323 · Received October 3, 2014

    Report

    Report Number
    4184323
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    August 13, 2014
    Report Date
    October 3, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US

    Narratives

    Description of Event or Problem · 1

    THE ORIGINAL DESIGN NAV-RING FUNCTIONALITY IS UNRESPONSIVE OR INTERMITTENT. THIS IS AN ONGOING ISSUE AT THIS FACILITY OVER THE LAST 4 MONTHS. ALL V-60 DEVICES ARE AFFECTED. THE FACILITY HAS BEEN IN CONTACT WITH THE MANUFACTURER AND THE MANUFACTURER HAS BEEN ON SITE TO INSPECT/REPAIR AFFECTED UNITS. HOWEVER, THE PROBLEM CONTINUES TO RECUR. THE MANUFACTURER HAS IDENTIFIED THE CAUSE OF THE PROBLEM, BUT WILL NOT REPLACE THE DEFECTIVE PART UNTIL THE DEVICE ACTUALLY FAILS. DUE TO ORIGINAL NAV-RING DEVICE DESIGN, ALL DEVICES WILL FAIL EVENTUALLY.AS A DIRECT RESULT OF INTITAL DESIGN, THE NAV RING IS INTERMITTENTLY OPERATIONAL, MAKING IT DIFFICULT TO SELECT PROPER PATIENT SETTINGS FOR THERAPY ON THE V-60 VENTILATOR.SYMPTOM: THE ORIGINAL DESIGN NAV-RING FUNCTIONALITY IS UNRESPONSIVE OR INTERMITTENT.CAUSE: THE ORIGINAL DESIGN FRONT BEZEL HAS A LOCATING NOTCH INTO THE PLASTIC AND THE NAV-RING OVERLAY HAS A LOCATING CUT-OUT, BOTH WERE USED FOR ALIGNMENT DURING MANUFACTURING AND SERVICE. IT HAS BEEN DETERMINED THAT THE NAV-RING CUT-OUT IS SUSCEPTIBLE TO LIQUID INGRESS CAUSING THE NAV-RING TO BE NON-RESPONSIVE. THIS TYPICALLY OCCURS WHEN CLEANING AGENTS WERE SPRAYED DIRECTLY AND REPEATEDLY ONTO THE NAV-RING ASSEMBLY, WHICH CONFORMS TO CLEANING INSTRUCTIONS.REMEDY: REPLACE THE ORIGINAL NAV-RING BY INSTALLING A 2ND GENERATION FRONT BEZEL WHICH REMOVE THE MOLDED NOTCH IN THE UI FRONT BEZEL AS WELL AS THE CUT-OUT IN THE NAV-RING OVERLAY. THIS WILL IMPROVE THE ROBUSTNESS OF THE NAV-RING ASSEMBLY AND GREATLY REDUCE THE SUSCEPTIBILITY OF LIQUID INGRESS.======================MANUFACTURER RESPONSE FOR BI-PAP VENTILATOR, V-60 (PER SITE REPORTER).======================MANUFACTURER WILL ADDRESS THE ISSUE ONLY AFTER THE NAVIGATION RING FAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617341 V-60 VENTILATOR, FACILITY, CONTINUOUS USE CBK RESPIRONICS CALIFORNIA, INC. V-60 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 *