BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VYNTUS SPIRO LAPTOP

    MDR report key: 20243853 · Received September 18, 2024

    Report

    Report Number
    9615102-2024-00156
    Event Type
    Malfunction
    Date Received
    September 18, 2024
    Date of Event
    August 21, 2024
    Report Date
    September 18, 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

    THE PROVIDED PICTURES CONFIRMED THAT THE KEYBOARD IS BENT UPWARDS WHERE THE BATTERY IS SITTING. AS THE DEVICE WAS NOT RETURNED, A SPECIFIC ROOT-CAUSE CAN NOT BE DETERMINED. THE MOST PROBABLE ROOT CAUSE CAN BE ATTRIBUTED TO A SWOLLEN BATTERY. 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 SPIRO LAPTOP FROM DELL IS PUSHING UP BECAUSE OF A SWOLLEN BATTERY. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1344474 VYNTUS SPIRO LAPTOP CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION BTY VYAIRE MEDICAL GMBH VYNTUS SPIRO LAPTOP 34250892904925

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown