BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V60 VENTILATOR

    MDR report key: 4960480 · Received August 3, 2015

    Report

    Report Number
    2031642-2015-01472
    Event Type
    Injury
    Date Received
    August 3, 2015
    Date of Event
    June 27, 2015
    Report Date
    July 7, 2015
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    PMA / PMN Number
    K082660
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED AFTER PHILIPS OBTAINS MORE INFORMATION CONCERNING THIS EVENT. PATIENT INFORMATION WAS REQUESTED AND THE CUSTOMER STATES THAT THE INFORMATION WILL BE PROVIDED AT A LATER TIME. (B)(4).

    Additional Manufacturer Narrative · 1

    THE MANUFACTURERS SERVICE ENGINEER (FSE) WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM. THE FSE VERIFIED THE REPORTED ERROR CODE IN THE DIAGNOSTIC LOG. THE FSE REPLACED THE DATA ACQUISITION TO MOTOR CONTROLLER CABLE AND INSTALLED A RETENTION BRACKET ON THE UNIT AS A PRECAUTIONARY MEASURE. NO PARTS HAVE RETURNED FOR FAILURE INVESTIGATION AT THIS TIME. THE DETERMINATION COULD NOT BE MADE THAT THE DEVICE FAILED TO MEET SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE VENTILATOR SHUT DOWN WHILE TRANSPORTING A PATIENT AND ALARMED WITH DATA ACQUISITION PCBA ADC REFERENCE FAILED. THE CUSTOMER REPORTED THAT THE PATIENT DESATURATION DROPS DOWN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE VENTILATOR SHUT DOWN WHILE TRANSPORTING A PATIENT AND ALARMED WITH DATA ACQUISITION PCBA ADC REFERENCE FAILED. THE CUSTOMER REPORTED THAT THE PATIENT DESATURATION DROPS DOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504752 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention