BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 4093524 · Received September 16, 2014

    Report

    Report Number
    2031642-2014-01048
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Report Date
    August 19, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION / ROOT CAUSE: THE DATA ACQUISITION PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) TO MOTOR CONTROLLER PCBA CABLE WAS TESTED AND NO FAILURES WERE IDENTIFIED. THIS REPORT IS BEING SUBMITTED AS PART OF THE REMEDIATION FOR CAPA (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR WAS ALARMING DUE TO PRESSURE SENSORS FAILURE. THE CUSTOMER REPORTED THE DEVICE WAS NOT IN USE THEREFORE THERE WAS NO PATIENT INVOLVEMENT OR HARM. AS REPORTED, A PRESSURE SENSORS FAILURE WHILE IN USE IN NORMAL VENTILATION OPERATION MAY AFFECT THE ACCURACY OF THE SYSTEM PRESSURE MEASUREMENT AND MAY RESULT IN THE UNIT GOING VENT INOP. A VENT INOP ALARM DISPLAYS ON THE SCREEN, TURNS ON REMOTE ALARM INTERFACES, AND DISABLES OXYGEN FLOW AND BLOWER OPERATION. THE MANUFACTURERS FIELD SERVICE ENGINEER (FSE) WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM AND REPORTED TESTING OF THE UNIT PASSED DURING CHECKOUT. THE FSE REPLACED THE DATA ACQUISITION PCB TO MOTOR CONTROLLER PCB BOARD CABLE AS A PRECAUTION. APPLICABLE FINAL TESTING WAS PERFORMED PER OPERATING SPECIFICATIONS AND PASSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572566 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC. V60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1