BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIVO 50 SYSTEM

    MDR report key: 3449915 · Received October 7, 2013

    Report

    Report Number
    9617566-2013-00004
    Event Type
    Malfunction
    Date Received
    October 7, 2013
    Date of Event
    September 6, 2013
    Report Date
    September 11, 2013
    Manufacturer
    BREAS MEDICAL AB
    Product Code
    NOU
    PMA / PMN Number
    K123144
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO GE HEALTHCARE THAT THE VENTILATOR HANDLE SNAPPED WHEN THE CAREGIVER LIFTED THE UNIT, AND THE VENTILATOR LANDED ON THE FLOOR. THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507448 VIVO 50 SYSTEM CONTINUOUS VENTILATOR NOU BREAS MEDICAL AB

    Patients

    Seq Age Sex Outcome Treatment
    1