BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 6171240 · Received December 13, 2016

    Report

    Report Number
    2031642-2016-03446
    Event Type
    Malfunction
    Date Received
    December 13, 2016
    Report Date
    November 15, 2016
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Removal / Correction Number
    Z-2061-2017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER REPLACED THE V60 DATA ACQUISITION (DA) TO MOTOR CONTROLLER (MC) CABLE/MOTOR CONTROLLER (MC) BRACKET RETROFIT KIT. UNIT PASSED THE REQUIRED TEST OF THE PERFORMANCE VERIFICATION SUCCESSFULLY.

    Additional Manufacturer Narrative · 1

    CORRECTED. THE FIELD SERVICE ENGINEER REPLACED THE V60 DATA ACQUISITION (DA) TO MOTOR CONTROLLER (MC) CABLE/MOTOR CONTROLLER (MC) BRACKET RETROFIT KIT. UNIT PASSED THE REQUIRED TEST OF THE PERFORMANCE VERIFICATION SUCCESSFULLY. THE DETERMINATION COULD NOT BE MADE THAT THE DEVICE FAILED TO MEET SPECIFICATIONS. THE DEVICE WAS NOT BEING USED FOR TREATMENT WHEN THE REPORTED EVENT OCCURRED, AND THERE IS A RELATIONSHIP OF THE DEVICE TO THE REPORTED PROBLEM. NO PARTS RETURNED TO FAILURE INVESTIGATION; THEREFORE, THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. IF PARTS ARE RETURNED, THE COMPLAINT WILL BE REOPENED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE UNIT HAS AN ERROR CODE MESSAGE OF DATA ACQUISITION/PRINTED CIRCUIT BOARD ASSEMBLY/ ANALOG DIGITAL CONVERTER (DA) PCBA ADC FAILED. THE UNIT WAS IN CLINICAL AT THE TIME THE REPORTED ISSUE WAS DISCOVERED; HOWEVER, THERE WAS NO HARM TO THE PATIENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE UNIT HAS AN ERROR CODE MESSAGE OF DATA ACQUISITION/PRINTED CIRCUIT BOARD ASSEMBLY/ ANALOG DIGITAL CONVERTER (DA) PCBA ADC FAILED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820015 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60

    Patients

    Seq Age Sex Outcome Treatment
    1