BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALMTOP VENTILATOR, MODELS PTV-8, PTV-10

    MDR report key: 6115232 · Received November 18, 2016

    Report

    Report Number
    2031702-2016-01467
    Event Type
    Injury
    Date Received
    November 18, 2016
    Date of Event
    October 17, 2016
    Report Date
    November 18, 2016
    Manufacturer
    CAREFUSION, INC
    Product Code
    CBK
    PMA / PMN Number
    K070594
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS OF INVESTIGATION: CAREFUSION CERTIFIED SERVICE TECHNICIAN WAS NOT ABLE TO DUPLICATE THE REPORTED COMPLAINT (UNIT FAILED). ALL TESTING¿S WAS PERFORMED BY USING A KNOWN GOOD TEST PATIENT CIRCUIT, AS WELL AS A KNOWN GOOD AC ADAPTER. THE VENTILATOR POWERED ON AND BOOT UP WITH NO ISSUES AND PASSED 68.5 HOURS EXTENDED TESTS AT THE CUSTOMER'S SETTINGS. THE VENTILATOR ALSO PASSED FINAL TEST WHICH INCLUDES MANY VENTILATION AND ALARM FUNCTIONS. FURTHERMORE INTERNAL INSPECTIONS WERE DONE ON THE REPORTED VENTILATOR AND NO ANOMALIES WERE REVEALED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE VENTILATOR FAILED WHILE BEING USED ON THE PATIENT. THERE WAS NO HARM TO ANY PATIENT OR CLINICIAN NOR ANY REPORT OF ALLEGATIONS OF THE VENTILATOR ASSOCIATED TO THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764311 PALMTOP VENTILATOR, MODELS PTV-8, PTV-10 VENTILATOR, CONTINUOUS, FACILITY USE CBK CAREFUSION, INC REVEL VENTILATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention