BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO I

    MDR report key: 430602 · Received November 27, 2002

    Report

    Report Number
    8010042-2002-00311
    Event Type
    Malfunction
    Date Received
    November 27, 2002
    Date of Event
    November 1, 2002
    Report Date
    November 26, 2002
    Manufacturer
    SIEMENS ELEMA AB
    Product Code
    CBK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ERROR CODE 28, 20004. DEFECTIVE LOUDSPEAKER. THE FSE REPORTS THERE WAS NO TONE. THERE WAS NO PT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention