BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 2110958 · Received March 18, 2011

    Report

    Report Number
    8010042-2011-00039
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 25, 2011
    Report Date
    February 25, 2011
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K062793
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THE VENTILATOR WAS IN USE ON A PT, THE RESPIRATORY RATE ROSE TO 60 BREATHS PER MINUTE WITHOUT USER INTERACTION. THE INTERNAL LEAKAGE TEST FAILED DURING THE SUBSEQUENT PRE-USE CHECK. (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