BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 4058604 · Received August 25, 2014

    Report

    Report Number
    8010042-2014-00380
    Event Type
    Malfunction
    Date Received
    August 25, 2014
    Date of Event
    May 20, 2014
    Report Date
    July 29, 2014
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EDI-CATHETER HAS BEEN RETURNED AND VISUAL EXAMINATION SHOWS THAT IT HAS A CRACK AT THE 55CM MARK, A PLACE WHICH CAN BE ON THE INVASIVE PART OF THE EDI CATHETER. THE INVESTIGATION IS ONGOING AND FURTHER INFO SURROUNDING THE EVENT HAS BEEN SOUGHT. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EDI CATHETER THAT HAD BEEN IN USE FOR 22 DAYS WAS LEAKING OF MEDICINES/NUTRITION AROUND THE TRACHEOSTOMA. CHEST X-RAY WAS DONE 2 TIMES TO CONFIRM THE PLACEMENT OF THE CATHETER. THE PLACEMENT WAS DETERMINED AS CORRECT. HOWEVER, A DISTINCT BUBBLE WAS NOTED. THE EDI CATHETER WAS REMOVED WHEREUPON A CRACK ALONGSIDE THE EDI CATHETER WAS OBSERVED. THERE WAS NO PT HARM. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514974 SERVO-I CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1