BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISPAN TM SULFUR HEXAFLUORIDE GAS

    MDR report key: 1476262 · Received July 2, 2009

    Report

    Report Number
    2518435-2009-00006
    Event Type
    Malfunction
    Date Received
    July 2, 2009
    Report Date
    June 10, 2009
    Manufacturer
    AIR LIQUIDE HEALTHCARE AMERICA CORPORATION
    Product Code
    LPO
    PMA / PMN Number
    P900067
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: ANALYSIS OF THE RETURNED PRODUCT BY GAS CHROMATOGRAPH (GC) SHOWED THAT THE PRODUCT MET PURITY SPECIFICATION AND THAT NO UNUSUAL PEAKS WERE SEEN COMPARED TO THE ORIGINAL GC. A CHECK OF THE BATCH PRODUCTION RECORDS SHOWED THAT THE ORIGINAL GC ANALYSIS MET PURITY SPECIFICATION. THERE HAVE BEEN NO OTHER REPORTS INVOLVING THIS LOT NUMBER. NO CONCLUSION CAN BE DRAWN. (B) (4).

    Description of Event or Problem · 1

    A FACILITY REPORTED THAT THE PRODUCT DID NOT LAST AS LONG AS ANTICIPATED ON 4 PATIENTS. NO PATIENT IDENTIFIERS WERE PROVIDED FOR ANY OF THE AFFECTED PATIENTS. NO OUTCOMES WERE PROVIDED FOR ANY OF THE AFFECTED PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISPAN TM SULFUR HEXAFLUORIDE GAS PRODUCT CODE LPO/INTRAOCULAR GAS LPO AIR LIQUIDE HEALTHCARE AMERICA CORPORATION SF6, 20 G 905503

    Patients

    Seq Age Sex Outcome Treatment
    1