BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERVO-I

    MDR report key: 2110569 · Received May 26, 2011

    Report

    Report Number
    8010042-2011-00085
    Event Type
    Injury
    Date Received
    May 26, 2011
    Date of Event
    May 6, 2011
    Report Date
    May 9, 2011
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K062793
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THE VENTILATOR WAS CONNECTED TO A PT, IT WENT BY ITSELF FROM THE VENTILATION MODE TO THE STANDBY MODE. THE HOSP REPORTED THAT THERE WAS PT INJURY BUT DID NOT RELEASE EXTENT OF INJURY. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERVO-I CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1