BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANES CIRCUITS

    MDR report key: 2097226 · Received May 11, 2011

    Report

    Report Number
    2242551-2011-00003
    Event Type
    Malfunction
    Date Received
    May 11, 2011
    Date of Event
    April 13, 2011
    Report Date
    May 11, 2011
    Manufacturer
    VITAL SIGNS, INC.
    Product Code
    CAI
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    2242551-04/29/11-004-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PT INFO HAS BEEN MADE AVAILABLE. THE HME FILTER WAS RETURNED AND EVALUATED BY GE HEALTHCARE ENGINEERS. SAMPLES FROM IN-HOUSE INVENTORY WERE ALSO DRAWN PER A SAMPLING PLAN AND EVALUATED. IT WAS DETERMINED THAT A PLASTIC MEMBRANE OCCLUDED THE MAJORITY OF THE INTERNAL OPENING OF THE FILTER. THE ROOT CAUSE IS BELIEVED TO BE THAT THE POSITION OF THE MOLD AND THE TORQUE APPLIED TO THE MOLD DURING THE PLASTIC HOUSING MFG WERE NOT SET PROPERLY RESULTING IN A REMNANT PLASTIC MEMBRANE. IT WAS DETERMINED THAT THE PART INSPECTION PROCESS WAS NOT ADEQUATE TO DETECT THIS DEFECT. THE AFFECTED PRODUCTS WERE PLACED ON SHIP HOLD TO CONTAIN THE DEFECT. ALL POTENTIALLY AFFECTED PARTS STILL IN GE HEALTHCARE'S POSSESSION HAVE BEEN REWORKED AND RE-INSPECTED PER NEW TEST PROCEDURE. GE HEALTHCARE HAS INITIATED A RECALL OF THE POTENTIALLY DEFECTIVE UNITS UNDER CORRECTION / REMOVAL NUMBER: 2242551-04/29/11-004-R. IT WAS DETERMINED DURING EVAL THAT THE FILTER WAS MANUFACTURED SOMETIME BETWEEN (B)(6) 2011.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT COULD NOT BE VENTILATED. THE CONNECTION TO THE OXYGEN SOURCE WAS VIA THE ANES CIRCUIT (ANESTHESIA CIRCUIT) CONTAINING AN IN-LINE MOISTURE FILTER (HME FILTER). UPON INSPECTION, THE 5701 HME FILTER WITHIN THE ANESTHESIA CIRCUIT WAS FOUND TO BE OCCLUDED BY A PIECE OF PLASTIC. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANES CIRCUITS ANESTHESIA CIRCUIT CAI VITAL SIGNS, INC. A4U52X1X 11090A

    Patients

    Seq Age Sex Outcome Treatment
    1