BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VYNTUS SPIRO TP SPIROMETER

    MDR report key: 19678185 · Received July 5, 2024

    Report

    Report Number
    9615102-2024-00152
    Event Type
    Malfunction
    Date Received
    July 5, 2024
    Date of Event
    June 5, 2024
    Report Date
    July 5, 2024
    Manufacturer
    VYAIRE MEDICAL GMBH
    Product Code
    BTY
    UDI-DI
    34250892904925
    PMA / PMN Number
    K071753
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    AT THE TIME OF THIS REPORT, THE DEFECTIVE LAPTOP HAS NOT YET BEEN RETURNED, SO NO INVESTIGATION COULD BE PERFORMED. ONCE THE LAPTOP HAS BEEN RETURNED AND INVESTIGATED, A FOLLOW UP REPORT WILL BE SUBMITTED. THE BROKEN LAPTOP WILL BE REPLACED. THE RISK EVALUATION RESULTS IN A RISK ACCEPTANCE LEVEL OF A MEDIUM ACCEPTABLE HEALTH RISK.

    Description of Event or Problem · 0

    THE CUSTOMER COMPLAINED THAT THE BATTERY OF THE LAPTOP IS SWOLLEN AND THE USB PORTS ARE NOT WORKING. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    959615 VYNTUS SPIRO TP SPIROMETER CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION BTY VYAIRE MEDICAL GMBH 34250892904925

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown