BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALMTOP VENTILATOR, MODELS PTV-8, PTV-10

    MDR report key: 6101048 · Received November 14, 2016

    Report

    Report Number
    2031702-2016-01413
    Event Type
    Malfunction
    Date Received
    November 14, 2016
    Date of Event
    March 18, 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
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CAREFUSION COMPLAINT NUMBER (B)(4). THE AC POWER ASSEMBLY WAS RECEIVED FOR EVALUATION. AN EVALUATION OF THE DEVICE DUPLICATED THE REPORTED ISSUE AND FOUND THE AC LEMO CONNECTOR PIN 2 IS BURNT. 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

    THE CUSTOMER REPORTED THAT THE UNIT WOULD NOT BOOT UP ALL THE WAY AND ALL OF THE LEDS WERE FLASHING. WHILE IN SERVICE, IT WAS DISCOVERED THAT THE UNIT HAD BURNT COMPONENTS. THIS REPORTABLE ISSUE WAS DISCOVERED WHILE IN SERVICE, THEREFORE THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749784 PALMTOP VENTILATOR, MODELS PTV-8, PTV-10 VENTILATOR, CONTINUOUS, FACILITY USE CBK CAREFUSION, INC PTV AC ADAPTER

    Patients

    Seq Age Sex Outcome Treatment
    1