BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISPAN TM GAS TANK REGULATOR

    MDR report key: 1784907 · Received June 30, 2010

    Report

    Report Number
    2518435-2010-00005
    Event Type
    Malfunction
    Date Received
    June 30, 2010
    Date of Event
    May 1, 2010
    Report Date
    June 1, 2010
    Manufacturer
    AIR LIQUIDE HEALTHCARE AMERICA CORPORATION
    Product Code
    LPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE FACILITY DID NOT PROVIDE A LOT NUMBER OR ANY IDENTIFICATION TRACEABLE TO THE MFG PROCESS. IT WAS REPORTED BY THE FACILITY THAT THE REGULATOR USED IN THIS CASE WAS THE "OLD STYLE" (DUAL DIAL GAUGE) WHICH WAS OUT OF WARRANTY AND HAD BEEN DISCONTINUED SEVERAL YRS AGO. THIS REPORT MAILED INTO THE FDA ON: (B)(4) 2010.

    Description of Event or Problem · 1

    A FACILITY REPORTED THAT A REGULAR FAILED TO DELIVER GAS INTO THE SYRINGE. AN ALTERNATIVE PROCEDURE WAS PERFORMED. THE REGULATOR THAT MALFUNCTIONED WAS THE "OLD STYLE" (DUAL DIAL GAUGE) WHICH WAS OUT OF WARRANTY AND HAD BEEN DISCONTINUED FOR SEVERAL YRS. THE EVENT DATE WAS NOT PROVIDED. NO PT IDENTIFIERS WERE PROVIDED. THE PT'S OUTCOME WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISPAN TM GAS TANK REGULATOR LPO/INTRAOCULAR LENS LPO AIR LIQUIDE HEALTHCARE AMERICA CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1