BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 3820136 · Received April 3, 2014

    Report

    Report Number
    2031642-2014-00233
    Event Type
    Malfunction
    Date Received
    April 3, 2014
    Report Date
    March 12, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    SUPPLEMENTAL REPORT

    Additional Manufacturer Narrative · 1

    EVAL AND SERVICE OF DEVICE PENDING.

    Description of Event or Problem · 1

    THE MANUFACTURERS SERVICE TECHNICIAN WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM. THE SERVICE TECHNICIAN REPLACED THE DATA ACQUISITION PCB TO MOTOR CONTROLLER PCB CABLE AS A PRECAUTION TO ADDRESS THE REPORTED PROBLEM. FINAL APPLICABLE TESTING WAS COMPLETED WITH NO FURTHER FAULT REPORTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE UNIT WENT VENT INOP. REVIEW OF THE DRPT NOTED A DA PCBA ADC FAILURE OCCURRENCE VENT INOP IS A HIGH PRIORITY CONDITION THAT PRECLUDES SAFE OPERATION OF THE VENTILATOR. A VENT INOP ALARM DISPLAY ON THE SCREEN, TURNS ON REMOTE ALARM INTERFACE, AND DISABLES OXYGEN FLOW AND BLOWER OPERATION. THE PT MUST BE PLACED ON ANOTHER MEANS OF VENTILATORY SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203056 V60 VENTILATOR VENTILATOR, CONTINUOUS MNT RESPIRONICS CALIFORNIA, INC. V60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1