BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALMTOP VENTILATOR, MODELS PTV-8, PTV-10

    MDR report key: 6883930 · Received September 21, 2017

    Report

    Report Number
    2031702-2017-01944
    Event Type
    Malfunction
    Date Received
    September 21, 2017
    Date of Event
    August 24, 2017
    Report Date
    October 18, 2017
    Manufacturer
    VYAIRE MEDICAL, INC
    Product Code
    CBK
    PMA / PMN Number
    K070594
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS OF INVESTIGATION: THIS UNIT WAS FIELD SERVICED BY A VYAIRE MEDICAL AUTHORIZED SERVICE TECHNICIAN. THE SERVICE TECHNICIAN WAS ABLE TO VERIFY THE CUSTOMER'S REPORTED ISSUE DURING TESTING AND EVALUATION. THE SERVICE TECHNICIAN REPLACED THE BACK LIGHT INVERTER BOARD TO ADDRESS THE CUSTOMER'S REPORTED ISSUE.

    Additional Manufacturer Narrative · 1

    RESULTS OF INVESTIGATION: VYAIRE MEDICAL WAS NOT ABLE TO DUPLICATE THE CUSTOMER¿S REPORTED ISSUE DURING TESTING AND EVALUATION. THE BACK LIGHT INVERTER BOARD WAS INSTALLED WITH THE GOLDEN TESTING VENTILATOR AND FOUND THE VENTILATOR PASSED THE INITIAL CHECK - IN TEST AND ALARMED PROPERLY BOTH AUDIBLY AND VISUALLY. THE VENTILATOR PASSED THE INITIAL PTV FINAL TEST AND PASSED THE FULL MAIN DISPLAY CALIBRATION TEST. THE VENTILATOR ALSO PASSED A 4 HOUR DURATION TEST AND ALL BENCH TEST¿S. VISUAL INSPECTION OF THE UNIT DID NOT REVEAL ANY ANOMALIES.

    Description of Event or Problem · 1

    IT WAS REPORTED TO VYAIRE MEDICAL THAT THE MAIN DISPLAY WAS BLANK. IT IS UNKNOWN WHETHER THERE WAS PATIENT INVOLVEMENT ASSOCIATED WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662191 PALMTOP VENTILATOR, MODELS PTV-8, PTV-10 VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL, INC ENVE

    Patients

    Seq Age Sex Outcome Treatment
    1