BEUDAMED
    FDA Adverse Event Other Summary report: N

    SERVO-I

    MDR report key: 3121755 · Received May 8, 2013

    Report

    Report Number
    8010042-2013-00066
    Event Type
    Other
    Date Received
    May 8, 2013
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K062793
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT AS REPORTED IS NOT INDICATIVE OF A DEVICE MALFUNCTION OF THE EDI CATHETER. INFORMATION FROM THE HOSPITAL ABOUT THE PROCEDURES FOR USE, INFORMATION SURROUNDING THE EVENT, AND ADDITIONAL PATIENT SPECIFICS HAS NOT BEEN RECEIVED DESPITE SEVERAL ATTEMPTS TO OBTAIN IT. (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202455 SERVO-I CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1