BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 3150004 · Received June 3, 2013

    Report

    Report Number
    8010042-2013-00086
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K062793
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MORE INFORMATION SURROUNDING THE EVENT HAS BEEN SOUGHT. A SUPPLEMENTAL MEDWATCH WILL BE PROVIDED WHEN INVESTIGATION IS FINISHED. REFERENCE EXEMPTION #: (B)(4).

    Description of Event or Problem · 1

    PLEASE REFER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243180 SERVO-I CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1