BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 3910318 · Received July 2, 2014

    Report

    Report Number
    2031642-2014-00599
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Report Date
    June 7, 2014
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    DATE RECEIVED BY MFR DATE: 08/29/2014. THIS DA BOARD WAS TESTED AND NO FAILURES WERE IDENTIFIED. THIS REPORT IS BEING SUBMITTED AS PART OF THE REMEDIATION FOR (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE VENTILATOR ALARMED AND SHUTDOWN DURING NORMAL VENTILATION OPERATION DUE TO A VENT INOP DATA ACQUISITION PCBA ADC FAILURE. THE CUSTOMER REPORTED THE DEVICE WAS IN USE ON A PATIENT AND THERE WAS NO PATIENT HARM. A VENT INOP CONDITION DURING 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. THE MANUFACTURERS FIELD SERVICE ENGINEER (FSE) WAS ABLE TO DUPLICATE THE REPORTED PROBLEM. THE FSE REPORTED THE DATA ACQUISITION PCB BOARD WAS REPLACED TO CORRECT THE REPORTED PROBLEM. FINAL APPLICABLE TESTING WAS COMPLETED PER OPERATING SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387197 V60 VENTILATOR VENTILATOR, CONTINUOUS MNT RESPIRONICS CALIFORNIA, INC. V60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1