BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VYNTUS WALK 6MWT TABLET W. APP

    MDR report key: 19123956 · Received April 17, 2024

    Report

    Report Number
    3010838917-2024-00114
    Event Type
    Malfunction
    Date Received
    April 17, 2024
    Date of Event
    January 18, 2024
    Report Date
    April 17, 2024
    Manufacturer
    VYAIRE MEDICAL, INC. (CAREFUSION GERMANY 234 GMBH)
    Product Code
    DQA
    UDI-DI
    54250892904899
    PMA / PMN Number
    K142959
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DURING INVESTIGATION A NEW POTENTIAL RISK HAS BEEN IDENTIFIED. THEREFORE THE BECOME AWARE DATE CHANGED TO THE DATE OF THE CLINICAL RISK ASSESSMENT REQUEST (19-MAR-2024). THE DECISION TREES HAVE BEEN UPDATED ACCORDINGLY. THE LENOVO TABLET IS A THIRD PARTY IT EQUIPMENT WHICH IS NOT FURTHER INVESTIGATED BY VYAIRE. LENOVO HAS THE APPROPRIATE DECLARATION OF CONFORMITY AND ADHERES TO ALL APPLICABLE SAFETY STANDARDS. THE USAGE OF TABLETS WHICH FULFIL APPLICABLE SAFETY STANDARDS IS STATE OF THE ART. THE MOST LIKELY ROOT-CAUSE IS A BATTERY FAILURE OF THE LENOVO TABLET. THE BROKEN TABLET WAS REPLACED ON THE (B)(6) 2024. 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 LENOVO TABLET IS SWOLLEN. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1856524 VYNTUS WALK 6MWT TABLET W. APP Oximeter DQA VYAIRE MEDICAL, INC. (CAREFUSION GERMANY 234 GMBH) VYNTUS WALK 6MWT TABLET W. APP 54250892904899

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown