BEUDAMED
    FDA Adverse Event Other Summary report: N

    S5 GAS BLENDER

    MDR report key: 3803005 · Received May 1, 2014

    Report

    Report Number
    1718850-2014-00132
    Event Type
    Other
    Date Received
    May 1, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 4, 2014
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    DTX
    PMA / PMN Number
    K101046
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP DEUTSCHLAND MANUFACTURES THE S5 GAS BLENDER. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP, (B)(4). SORIN-GROUP DEUTSCHLAND. SORIN GROUP DEUTSCHLAND RECEIVED A REPORT THAT AT LOW FLOWS, THE DISPLAYED GAS FLOWS OF THE S5 GAS BLENDER WERE NOT STABLE. AN ACOUSTIC BEEPING WAS HEARD. THERE WAS NO REPORT OF PT INJURY. THE INVESTIGATION IS ONGOING. A F/U REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP DEUTSCHLAND RECEIVED A REPORT THAT AT LOW GAS FLOWS, THE DISPLAYED GAS FLOWS OF THE S5 GAS BLENDER WERE NOT STABLE. AN ACOUSTIC BEEPING WAS HEARD. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261907 S5 GAS BLENDER GAS CONTROL UNIT, CARDIOPULMONARY BYPASS DTX SORIN GROUP DEUTSCHLAND 25-40-46 NA

    Patients

    Seq Age Sex Outcome Treatment
    1