BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VYNTUS ONE PC

    MDR report key: 20243843 · Received September 18, 2024

    Report

    Report Number
    9615102-2024-00155
    Event Type
    Malfunction
    Date Received
    September 18, 2024
    Date of Event
    August 26, 2024
    Report Date
    September 18, 2024
    Manufacturer
    VYAIRE MEDICAL GMBH
    Product Code
    BZC
    UDI-DI
    04250892904719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    AS THE DEVICE WAS NOT RETURNED AND THE COMPLAINT COULD NOT BE CONFIRMED, A SPECIFIC ROOT-CAUSE COULD NOT BE DETERMINED. THE CUSTOMER RECEIVED A REPLACEMENT LAPTOP. THE DELL LAPTOP IS A THIRD PARTY DEVICE WHICH IS NOT FURTHER INVESTIGATED BY VYAIRE. DELL HAS THE APPROPRIATE DECLARATION OF CONFORMITY AND ADHERES TO ALL APPLICABLE SAFETY STANDARDS. THE USAGE OF LAPTOPS WHICH FULFIL APPLICABLE SAFETY STANDARDS IS STATE OF THE ART. THE CUSTOMER WILL BE INFORMED THAT A SWOLLEN BATTERY POSES A SAFETY RISK TO USERS AND PATIENTS. THEREFORE THE LAPTOP SHOULD BE RETURNED TO VYAIRE OR IF THAT IS NOT POSSIBLE, SCRAPPED IN ACCORDANCE WITH HAZARDOUS MATERIALS DISPOSAL. THE RISK EVALUATION OF THIS COMPLAINT RESULTS IN A RISK ACCEPTANCE LEVEL OF A MEDIUM ACCEPTABLE HEALTH RISK.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE KEYBOARD OF THE VYNTUS ONE LAPTOP FROM DELL IS PUFFED OUT, WHICH POSSIBLY COULD BE THE RESULT OF A SWOLLEN BATTERY. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1343483 VYNTUS ONE PC CALCULATOR, PULMONARY FUNCTION DATA BZC VYAIRE MEDICAL GMBH VYNTUS ONE PC 04250892904719

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown