BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO I

    MDR report key: 448698 · Received March 13, 2003

    Report

    Report Number
    8010042-2003-00069
    Event Type
    Malfunction
    Date Received
    March 13, 2003
    Date of Event
    January 21, 2003
    Report Date
    March 13, 2003
    Manufacturer
    SIEMENS-ELEMA AB/LIFE SUPPORT SYSTEMS DIVISION
    Product Code
    CBK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE VENTILATOR WAS CYCLING ON A PT AND THE PEEP LEVEL WOULD INCREASE TO 14-15 CMH2O, FROM A SET LEVEL OF 5 CMH2O. VENTILATOR WAS TAKEN OFF THE PT, PT WAS BAGGED AND THE VENTILATOR WAS SWAPPED OUT. THE VENTILAATOR WAS TAKEN TO THE BIO-MED DEPT. AN FSE FROM SIEMENS MEDICAL SYSTEMS, INC. WAS DISPATCHED TO THE CUSTOMER'S SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERVO I RESPIRATORY VENTILATOR CBK SIEMENS-ELEMA AB/LIFE SUPPORT SYSTEMS DIVISION 6487800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention