BEUDAMED
    FDA Adverse Event Death Summary report: N

    SERVO-I

    MDR report key: 3030682 · Received March 22, 2013

    Report

    Report Number
    8010042-2013-00041
    Event Type
    Death
    Date Received
    March 22, 2013
    Date of Event
    February 25, 2013
    Report Date
    February 27, 2013
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K062793
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION HAS COMMENCED. FURTHER INFORMATION SURROUNDING THE EVENT HAS BEEN SOUGHT. A SUPPLEMENTAL MEDWATCH WILL BE PROVIDED AFTER INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE EDI CATHETER WAS REMOVED FROM THE PATIENT, IT HAD CRACKED. THE LOWER PART OF THE EDI CATHETER WAS HANGING TOGETHER WITH HELP OF A STRING ELECTRODE. THE HOSPITAL FURTHER REPORTED THAT ON THE DAY OF THE INCIDENT THE PATIENT DEVELOPED AN ACUTE GASTRIC HEMORRHAGE AND DIED LATER. THE HOSPITAL CANNOT AT THIS TIME EXCLUDE WHETHER THE EDI CATHETER WAS CONTRIBUTORY TO THIS INCIDENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119427 SERVO-I CBK MAQUET CRITICAL CARE AB NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Death