BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERVO-I

    MDR report key: 3150052 · Received June 3, 2013

    Report

    Report Number
    3008355164-2013-00139
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 8, 2013
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EDI CATHETER HAD BEEN INSERTED IN THE PT FOR 7 DAYS. WHEN REMOVED FOR REPLACEMENT IT WAS NOTICED THAT ITS BOTTOM PART HAD COME OFF AND HAD REMAINED IN THE PT LEAVING THE EDI CATHETER'S WIRES EXPOSED. THE EDI CATHETER WAS FUNCTIONING UP TO THE TIME OF REMOVAL. (B)(4). REF MFR NUMBER: 8010042-2013-00090.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242818 SERVO-I CBK MAQUET CRITICAL CARE AB NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other