BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-S

    MDR report key: 1823433 · Received August 26, 2010

    Report

    Report Number
    8010042-2010-00172
    Event Type
    Malfunction
    Date Received
    August 26, 2010
    Date of Event
    June 15, 2010
    Report Date
    July 30, 2010
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K041223
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR GENERATED A TECHNICAL ERROR CODE INDICATING A COMMUNICATION FAILURE AND THAT THE INTERNAL LEAKAGE TEST FAILED 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