BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 4324690 · Received December 4, 2014

    Report

    Report Number
    8010042-2014-00553
    Event Type
    Malfunction
    Date Received
    December 4, 2014
    Date of Event
    November 9, 2014
    Report Date
    November 9, 2014
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION HAS COMMENCED. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN IT IS COMPLETED.

    Additional Manufacturer Narrative · 1

    THE EDI CATHETER WAS NOT RETURNED. THE COMPLAINT WAS A GENERAL PROBLEM WITH VENTING OF GASTRIC AIR VIA THE 6 FR. EDI CATHETER THAT IS USED FOR THE SMALLEST NEONATES. THE ADDITIONAL INFORMATION RECEIVED FROM THE FACILITY STATES THAT THERE WAS NO MALFUNCTION WITH THE EDI CATHETER. IN CONNECTION TO THAT THE EDI CATHETER WAS PLACED IN THE PATIENT A SMALL AMOUNT OF AIR WAS INJECTED TO VERIFY THAT IT WAS PLACED IN THE STOMACH AND THE SMALL AMOUNT OF AIR WENT IN FINE. THE PATIENT HAD NOT BEEN FED THROUGH THE EDI CATHETER. THE CAUSE OF THE REPORTED EVENT IS THEREFORE NOT A PRODUCT OR BATCH RELATED FAILURE IT IS THE SMALL SIZE OF THE LUMEN IN 6 FR. CATHETERS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS BEING TREATED WITH NIV NAVA (NON INVASIVE NEURALLY ADJUSTED VENTILATORY ASSIST) WITH AN INSERTED EDI CATHETER AND WAS DOING WELL. AFTER ABOUT 2 HOURS OF NIV NAVA TREATMENT, THE NURSE NOTED THAT THE ABDOMEN WAS DISTENTED AND THE EDI CATHETER WAS NOT VENTING GASTRIC AIR ADEQUATELY. A SECOND FEEDING CATHETER WAS INSERTED TO RELIEVE THE DISTENTION. THERE WAS NO PATIENT HARM. (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784693 SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1 14 DA