BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 2884207 · Received December 21, 2012

    Report

    Report Number
    2031642-2012-00557
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Report Date
    December 12, 2012
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    LOOSE CABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE VENTILATOR WENT VENT INOP AND ALARMED DURING USE ON A PATIENT DUE TO 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. THE MANUFACTURER'S SERVICE TECHNICIAN WAS ABLE TO DUPLICATE THE REPORTED PROBLEM WHILE TESTING THE DEVICE. THE SERVICE TECHNICIAN REPORTED THE DATA ACQUISITION BOARD RIBBON CABLE WAS NOT SEATED AND WHEN THE CABLE WAS TOUCHED THE REPORTED VENT INOP OCCURRED. THE SERVICE TECHNICIAN RESEATED THE RIBBON CABLE TO ADDRESS THE FINDING. APPLICABLE FINAL TESTING WAS COMPLETED AND PASSED TO OPERATING SPECIFICATIONS.

    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