BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 3971141 · Received April 29, 2014

    Report

    Report Number
    8010042-2014-00194
    Event Type
    Malfunction
    Date Received
    April 29, 2014
    Date of Event
    March 28, 2014
    Report Date
    March 31, 2014
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K062793
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PART HAS BEEN REQUESTED BACK FOR INVESTIGATION. A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED WHEN IT HAS BEEN COMPLETED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EDI CATHETER WAS REMOVED FROM THE PATIENT AFTER 6 DAYS OF USE. ON ITS REMOVAL IT WAS OBSERVED THAT THE EDI CATHETER HAD SPLIT. THERE WAS NO PATIENT HARM. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256179 SERVO-I CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR