BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALMTOP VENTILATOR, MODELS PTV-8, PTV-10

    MDR report key: 6035839 · Received October 17, 2016

    Report

    Report Number
    2031702-2016-01102
    Event Type
    Malfunction
    Date Received
    October 17, 2016
    Date of Event
    August 25, 2014
    Report Date
    October 17, 2016
    Manufacturer
    CAREFUSION, INC
    Product Code
    CBK
    PMA / PMN Number
    K070594
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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. CAREFUSION EXAMINED THE RETURNED AC ADAPTER. AN EXTERNAL INSPECTION SHOWED CORROSION ON THE AC POWER CORD RETAINING COLOR, MOST LIKELY DUE TO EXPOSURE TO WATER OR HIGH HUMIDITY. AFTER THE AC ADAPTER WAS OPENED, AN INTERNAL INSPECTION FOUND NO INDICATIONS OF SIMILAR CORROSION INSIDE THE DEVICE. SEVERAL COMPONENTS OF THE AC ADAPTER HAD OVERHEATED DUE TO WHAT APPEARS TO BE HIGH ELECTRIC CURRENT LEVELS. DUE TO THE EXTENSIVE COMPONENT AND CIRCUIT BOARD DAMAGE, THE ROOT CAUSE FOR THE DAMAGE COULD NOT BE DETERMINED. THE UNIT IS UN-REPAIRABLE AND WAS SCRAPPED. 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 BURNED MARK IN THE PLASTIC PART OF THE AC ADAPTER HOUSING. 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
    684297 PALMTOP VENTILATOR, MODELS PTV-8, PTV-10 VENTILATOR, CONTINUOUS, FACILITY USE CBK CAREFUSION, INC PTV AC ADAPTER

    Patients

    Seq Age Sex Outcome Treatment
    1