BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V60 VENTILATOR

    MDR report key: 4167073 · Received October 13, 2014

    Report

    Report Number
    2031642-2014-01177
    Event Type
    Injury
    Date Received
    October 13, 2014
    Date of Event
    September 19, 2014
    Report Date
    October 2, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION & SERVICE PENDING.

    Description of Event or Problem · 1

    THE MANUFACTURERS SERVICE TECHNICIAN REPLACED THE CPU AND POWER MANAGEMENT PCB BOARDS, BATTERY AND DATA ACQUISITION TO MOTOR CONTROLLER PCBS CABLE.

    Description of Event or Problem · 1

    THE INTERNATIONAL CUSTOMER REPORTED THE VENTILATOR ALARMED DUE TO A PRESSURE SENSORS FAILURE AND OPERATION STOPPED. THE CUSTOMER REPORTED THE DEVICE WAS IN USE ON A MALE PATIENT, AT SETTINGS: MODE S/T, IPAP 14HPA(CM H2O), EPAP 4HPA(CM H2O), RATE 10BPM, TI (TIMED INSP.) 1.0 SEC., RISE TIME 2, FIO2 30%. THE CUSTOMER REPORTED AN ALARM WAS GENERATED WHEN THERE WAS A REDUCTION IN THE PATIENT'S SPO2 SO A NURSE CHECKED THE PATIENT AND REPORTEDLY FOUND THAT THE VENTILATOR WAS NOT OPERATING. THE CUSTOMER REPORTED THE PATIENT'S SPO2 WAS 98% BEFORE THE OCCURRENCE AND IT REDUCED TO 70% AFTER THAT. AN OXYGEN MASK WAS PUT ON THE PATIENT ALTERNATIVELY AND THE PATIENTS CONDITION RETURNED. AFTER APPROXIMATELY 70 MINUTES A MANUFACTURERS SALES REPRESENTATIVE ARRIVED AT THE HOSPITAL AND REPORTEDLY CONFIRMED THE REPORTED PROBLEM AND REPORTED THE ALARM VOLUME WAS VERY LOW. THE PATIENT WAS PLACED ON ANOTHER UNIT WITH NO REPORT OF PERMANENT HARM. REVIEW OF THE DEVICE DIAGNOSTIC LOG NOTED CODES THAT INDICATE AN SPI BUS FAILURE. THE SPI BUS IS COMMUNICATION USED TO READ DATA FOR PRESSURE AND FLOW SENSORS. THIS FAILURE MAY RESULT IN A VENT INOP OCCURRENCE. A VENT INOP DURING NORMAL VENTILATION OPERATION WILL RESULT IN A VISUAL AND AUDIBLE ALARM AND PRECLUDES CONTINUED SAFE OPERATION OF THE VENTILATOR. THE USER MUST PROVIDE ALTERNATIVE VENTILATION AND HAVE THE VENTILATOR SERVICED. DEVICE EVALUATION AND SERVICE IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646048 V60 VENTILATOR VENTILATOR, CONTINUOUS MNT RESPIRONICS CALIFORNIA, INC. V60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention