BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-60 VENTILATOR

    MDR report key: 4066409 · Received August 29, 2014

    Report

    Report Number
    4066409
    Event Type
    Malfunction
    Date Received
    August 29, 2014
    Date of Event
    August 11, 2014
    Report Date
    August 29, 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

    SYMPTOM: THE ORIGINAL DESIGN NAV-RING FUNCTIONALITY IS UNRESPONSIVE OR INTERMITTENT.CAUSE: THE ORIGINAL DESIGN FRONT BEZEL HAS A LOCATING NOTCH (FIGURE 1) MOLDED 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.======================MANUFACTURER RESPONSE FOR RESPIRONICS V-60 VENTILATOR, V-60 VENTILATOR (PER SITE REPORTER).======================ACTION FOR PERFORMANCE - RETROFIT ON FAILURE.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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527982 V-60 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS CALIFORNIA INC. V-60 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *