BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALMTOP VENTILATOR, MODELS PTV-8, PTV-10

    MDR report key: 6100622 · Received November 14, 2016

    Report

    Report Number
    2031702-2016-01396
    Event Type
    Malfunction
    Date Received
    November 14, 2016
    Date of Event
    June 2, 2014
    Report Date
    November 14, 2016
    Manufacturer
    CAREFUSION, INC
    Product Code
    CBK
    PMA / PMN Number
    K070594
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 THE POWER ADAPTER WAS DAMAGED. PINS 3,4, AND 5 OF THE LEMO CONNECTOR WAS BURNT. CAREFUSION SCRAPPED THE ADAPTER AND SENT A REPLACEMENT TO THE CUSTOMER. 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 AND ON THE AC ADAPTER. 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
    749830 PALMTOP VENTILATOR, MODELS PTV-8, PTV-10 VENTILATOR, CONTINUOUS, FACILITY USE CBK CAREFUSION, INC PTV AC ADAPTER

    Patients

    Seq Age Sex Outcome Treatment
    1