BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 2880250 · Received December 19, 2012

    Report

    Report Number
    2031642-2012-00549
    Event Type
    Malfunction
    Date Received
    December 19, 2012
    Report Date
    December 11, 2012
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    OUT OF WARRANTY; NO MFG SERVICE REQUESTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE VENTILATOR WENT VENT INOP DURING USE ON A PATIENT DUE TO AN OCCURRENCE OF A DATA ACQUISITION PCBA ADC REFERENCE FAILURE. THE CUSTOMER REPORTED 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. AS THE DEVICE WAS OUT OF WARRANTY, THE MANUFACTURERS PRODUCT SUPPORT ENGINEER RECOMMENDED THE CUSTOMER CHECK THE CONNECTIONS OF THE DATA ACQUISITION TO MOTOR CONTROLLER CABLE. THE CUSTOMER REPORTED THE CONNECTIONS SEEMED OK BUT DISCONNECTED AND RECONNECTED THEM AS A PRECAUTION. THE CUSTOMER REPORTED HE WAS UNABLE TO DUPLICATE THE VENT INOP OCCURRENCE DURING CHECKOUT.

    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