BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEDATION SYSTEMS

    MDR report key: 2879560 · Received December 11, 2012

    Report

    Report Number
    3007143859-2012-00001
    Event Type
    Malfunction
    Date Received
    December 11, 2012
    Date of Event
    October 5, 2012
    Report Date
    December 6, 2012
    Manufacturer
    GLOBALMED INC.
    Product Code
    BSJ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT (I.E. DEVICE) WAS LEAK TESTED BY MFR PRIOR TO BEING RELEASED FOR SHIPMENT USING THE INDUSTRY STANDARD (ISO 63676:2000 ANNEX D). REQUEST WAS MADE TO RETURN TO MFR ONE UNOPENED CASE OF PRODUCT (B)(4) (10 PIECES) AS WELL AS THE ALLEGED DEFECTIVE SAMPLE TESTED AND REFERRED TO IN MAUDE EVENT REPORT ((B)(4)). ONLY THE ONE CASE OF UNOPENED PRODUCT WAS RETURNED TO MFR (LOT # 90815). ALL 10 PIECES WERE LEAK TESTED DURING THE ABOVE ISO STANDARD AND FOUND TO MEET THE STANDARD. ADDITIONALLY, ALL 10 PIECES WERE FOUND FREE OF ANY DEFECTS OR ABNORMALITIES. (B)(6) LETTER DATED (B)(6) 2012. INASMUCH AS THE ACTUAL SAMPLE "SCREENED" BY THE HOSPITAL AS DESCRIBED IN MAUDE EVENT REPORT (B)(4), AND FORMING THE BASIS OF THE "HEADACHE" COMPLAINT, WAS NOT RETURNED TO MFR FOR EVAL (DESPITE REPEATED REQUESTS), THE ROOT CAUSE OF THE "HEADACHE" COMPLAINED OF IN (B)(4) CANNOT BE DETERMINED OR ATTRIBUTED TO ANY MALFUNCTIONING OR DEFECTIVE PRODUCT. UPON INFO AND BELIEF, THE HOSPITAL HAS CONTINUED TO ORDER AND USE THE PRODUCT ((B)(4)) SUBSEQUENT TO FILING OF THE MAUDE EVENT REPORT. IT IS NOTED THAT THE MAUDE EVENT REPORT (B)(4) DOES NOT STATE THAT THE SAMPLE "SCREENED" WAS THE DIRECT CAUSE OF THE COMPLAINED OF "HEADACHE," MERELY THAT THERE WAS A 'HEADACHE" BY AN UNIDENTIFIED INDIVIDUAL AND THAT A PRODUCT SAMPLE WAS "SCREENED". IT ALSO IS NOTED THAT LOT'S CITED IN THE MAUDE REPORT ARE DIFFERENT THAN THOSE ALLEGED BY THE HOSPITAL'S REP, (B)(6), AS REQUIRING EVAL.

    Description of Event or Problem · 1

    SEE MAUDE EVENT REPORT (B)(4) INCLUDED WITH FDA LETTER DATED (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEDATION SYSTEMS RESPIRATORY MASK AND BREATHING CIRCUIT BSJ GLOBALMED INC. 90815

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK