BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 2855190 · Received December 3, 2012

    Report

    Report Number
    2031642-2012-00522
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Report Date
    November 20, 2012
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE 3RD PARTY BIOMEDICAL TECHNICIAN REPORTED THAT THE VENTILATOR ALARMED AND SHUT DOWN WHILE IN USE ON A PATIENT. THE HOSPITAL REPORTED THERE WAS NO PATIENT HARM. REVIEW OF THE DEVICE DIAGNOSTIC LOG HISTORY NOTED ALARMS DURING NORMAL VENTILATION MODE OPERATION INDICATING THE UNIT WAS RUNNING ON INTERNAL BATTERY, THE INTERNAL BATTERY WAS LOW, AND A SHUTDOWN DUE TO LOSS OF POWER UNTIL AC POWER WAS RESTORED. UPON EVALUATION, THE MANUFACTURER'S SERVICE TECHNICIAN REPORTED THE DEVICE WOULD NOT POWER ON. THE SERVICE TECHNICIAN REPLACED THE POWER SUPPLY AND THE POWER MANAGEMENT BOARD TO ADDRESS THE NO POWER CONDITION. DURING TESTING, THE SERVICE TECHNICIAN REPORTED THE UNIT WAS DISCONNECTED FROM AC POWER TO CHECK THE BATTERY AND THE UNIT WOULD NOT OPERATE ON THE BATTERY. THE SERVICE TECHNICIAN REPLACED THE BATTERY TO ADDRESS THE FINDING. APPLICABLE FINAL TESTING WAS COMPLETED AND PASSED TO SPECIFICATIONS. THIS EVENT IS ALSO BEING REPORTED AS A USER ERROR DUE TO FAILURE TO MAINTAIN THE BATTERY AS SPECIFIED. PER THE DEVICE USER MANUAL, THE BATTERY IS INTENDED FOR SHORT-TERM USE ONLY, NOT AS A PRIMARY SOURCE. THE USER MUST PAY CLOSE ATTENTION TO THE BATTERY'S CHARGE LEVEL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1