BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRODUCT VYNTUS ONE

    MDR report key: 18967065 · Received March 25, 2024

    Report

    Report Number
    9615102-2024-00146
    Event Type
    Malfunction
    Date Received
    March 25, 2024
    Date of Event
    February 29, 2024
    Report Date
    March 25, 2024
    Manufacturer
    VYAIRE MEDICAL, INC. (CAREFUSION GERMANY 234 GMBH)
    Product Code
    BZC
    UDI-DI
    04250892904696
    PMA / PMN Number
    K181524
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT THE SUPPORT ARM WAS INCORRECT HANDLED COMPARED TO THE INSTRUCTIONS STATED IN THE INSTRUCTION FOR USE. THE CUSTOMER WAS INFORMED ABOUT THE CORRECT HANDLING AND DIRECTED TO THE RELEVANT PAGE IN THE IFU. THIS INCIDENT IS CLASSIFIED WITH A RISK LEVEL OF MEDIUM AND IS AN ACCEPTABLE PATIENT RISK.

    Description of Event or Problem · 0

    THE CUSTOMER COMPLAINED THAT THE USS MODULE DETACHED FROM THE ARM AND AS A RESULT FELL ONTO THE PATIENT¿S FACE, WHICH WAS INJURED. THE PATIENT'S LIP WAS BRUISED AND CUT. FIRST AID WAS ADMINISTERED BY THE HEALTH CARE PROVIDER. THEY USED A COLD TISSUE AND COMPRESSION. NO FURTHER FIRST AID WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13764 PRODUCT VYNTUS ONE CALCULATOR, PULMONARY FUNCTION DATA BZC VYAIRE MEDICAL, INC. (CAREFUSION GERMANY 234 GMBH) VYNONE 04250892904696

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown