BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANES CIRCUITS

    MDR report key: 2146883 · Received June 1, 2011

    Report

    Report Number
    2242551-2011-00008
    Event Type
    Malfunction
    Date Received
    June 1, 2011
    Report Date
    June 1, 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
    NJ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PACKAGING WAS DISCARDED FOR THIS UNIT AND THE LOT # COULD NOT BE DETERMINED. A SAMPLE WAS NOT AVAILABLE FROM THE SITE, HOWEVER, THIS IS THE SAME ISSUE THAT WAS REPORTED IN MDR 2242551-2011-00002. IT WAS DETERMINED THAT A PLASTIC MEMBRANE OCCLUDED THE MAJORITY OF THE INTERNAL OPENING OF THE FILTERS. 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 A NEW TEST PROCEDURE. GE HEALTHCARE HAS INITIATED A RECALL OF THE POTENTIALLY DEFECTIVE UNITS UNDER CORRECTION / REMOVAL NUMBER: 2242551-04/29/11-004-R. DEVICE MANUFACTURE DATE IS NOT KNOWN AS THE CIRCUIT LOT WAS NOT RECORDED BY THE END USER. HOWEVER, FROM EVALUATION IT WAS DETERMINED THAT THE FILTER WAS MANUFACTURED BETWEEN 01/12/2011 AND 01/25/2011. THE DATE OF THE FIRST DISCOVERY OF THIS ISSUE AT THE SITE IS UNK. THIS SITE STATED THAT THEY HAD DISCOVERED THE ISSUE BEFORE RECEIVING THE RECALL NOTICE, BUT ONLY CONTACTED A GE HEALTHCARE REPRESENTATIVE AFTER RECEIVING THE RECALL NOTICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING OF ANES CIRCUITS BY THE SITE, THE CLINICIANS NOTICED OCCLUSION OF THE 5701 HME FILTERS WITHIN ANESTHESIA CIRCUITS. NO PT INVOLVEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANES CIRCUITS ANESTHESIA CIRCUIT CAI VITAL SIGNS, INC. A5U32X14

    Patients

    Seq Age Sex Outcome Treatment
    1