BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALMTOP VENTILATOR, MODELS PTV-8, PTV-10

    MDR report key: 6028793 · Received October 13, 2016

    Report

    Report Number
    2031702-2016-01067
    Event Type
    Malfunction
    Date Received
    October 13, 2016
    Date of Event
    September 2, 2014
    Report Date
    September 2, 2014
    Manufacturer
    CAREFUSION, INC
    Product Code
    CBK
    PMA / PMN Number
    K070594
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS OF INVESTIGATION: CAREFUSION WAS ABLE TO VERIFY THE REPORTED ISSUE. VISUAL INSPECTION REVEALED COMPONENT JP4 OF THE POWER FLEX WAS DAMAGED. PINS 2,3, AND 4 OF JP4 WERE BURNT. CAREFUSION REPLACED THE POWER FLEX TO ADDRESS THE REPORTED ISSUE. THIS COMPLAINT WAS INCLUDED IN A TWO-YEAR RETROSPECTIVE COMPLAINT REVIEW TO ASSESS MDR REPORTABILITY COMPLIANCE. THIS COMPLAINT WAS DEEMED TO MEET THE REQUIREMENTS FOR MDR SUBMISSION AND IS THEREFORE BEING SUBMITTED TO THE FDA.

    Description of Event or Problem · 1

    IT WAS REPORTED TO CAREFUSION THAT THE UNIT HAD A BURNT LEMO CONNECTOR ON THE VENTILATOR. IT IS UNKNOWN AT THIS TIME WHETHER THERE WAS ANY PATIENT INVOLVEMENT ASSOCIATED WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677960 PALMTOP VENTILATOR, MODELS PTV-8, PTV-10 VENTILATOR, CONTINUOUS, FACILITY USE CBK CAREFUSION, INC REVEL

    Patients

    Seq Age Sex Outcome Treatment
    1