BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-S

    MDR report key: 2110580 · Received May 26, 2011

    Report

    Report Number
    8010042-2011-00086
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    April 28, 2011
    Report Date
    May 5, 2011
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K041223
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCE EXEMPTION #: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR FAILED THE SAFETY VALVE TEST DURING PRE-USE CHECK. (B)(4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1