BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALMTOP VENTILATOR, MODELS PTV-8, PTV-10

    MDR report key: 5998879 · Received October 4, 2016

    Report

    Report Number
    2031702-2016-01009
    Event Type
    Malfunction
    Date Received
    October 4, 2016
    Date of Event
    July 19, 2016
    Report Date
    July 19, 2016
    Manufacturer
    CAREFUSION, INC
    Product Code
    CBK
    PMA / PMN Number
    K070594
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CAREFUSION WAS UNABLE TO VERIFY THE REPORTED ISSUE OF THE PIGTAIL ON THE UNIT NOT RECOGNIZING AC CONNECTION. DURING INITIAL BENCH TESTING WITH A SERVICE GOLDEN TESTING PTV UNIT, FOUND THE NEW PTV PIGTAIL CABLE AND THE PTV AC ADAPTER CABLE EXTENSION WAS DAMAGED AND UNABLE TO PERFORM BENCH TESTING. VISUAL INSPECTION REVEALED SOME OF THE PINS AND CONNECTORS WERE HEAVILY DAMAGED WITH SIGNS OF OVERHEATED AND BENDING. CAREFUSION SCRAPPED THE PTV PIGTAIL CABLE AND THE PTV AC ADAPTER CABLE EXTENSION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO CAREFUSION THAT THE PIGTAIL ON THE UNIT WAS NOT RECOGNIZING THE AC CONNECTION. WHILE IN SERVICE IT WAS DISCOVERED THAT THE CONNECTORS HAD SIGNS OF OVERHEATING. THIS REPORTABLE ISSUE WAS DISCOVERED WHILE IN SERVICE, THEREFORE THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649753 PALMTOP VENTILATOR, MODELS PTV-8, PTV-10 VENTILATOR, CONTINUOUS, FACILITY USE CBK CAREFUSION, INC REVEL

    Patients

    Seq Age Sex Outcome Treatment
    1