BEUDAMED
    FDA Adverse Event Other Summary report: N

    DRAGERSORB

    MDR report key: 2213798 · Received November 22, 2005

    Report

    Report Number
    9611500-2005-00037
    Event Type
    Other
    Date Received
    November 22, 2005
    Date of Event
    April 28, 2005
    Report Date
    November 21, 2005
    Manufacturer
    DRAGER MEDICAL AG & CO. KG
    Product Code
    BSF
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORTER WAS CONTACTED AND GAVE FOLLOWING ADDITIONAL INFO. THE REPORTER STATED, THAT THERE WAS NO PT INJURY. THE QUESTION, WHY IT TOOK 5 MONTHS BETWEEN DATE OF EVENT AND THE USER FACILITY REPORT WAS ANSWERED BY HOSPITAL INTERNAL INVESTIGATION; THE RESULTS OF THIS INVESTIGATION WAS NOT MADE AVAILABLE TO THE IMPORTER/MFR ON REQUEST. ALSO THE AFFECTED CO2 ABSORBENT WAS NOT BEEN MADE AVAILABLE FOR INVESTIGATION AT MFR SITE, AS REQUESTED. THE INITIAL REPORTER WAS NOT ABLE TO PROVIDE INFO ABOUT THE ANESTHESIA MACHINE ON WHICH THE OCCURRENCE WAS REPORTED. DUE TO THE LACK OF FURTHER FEASABLE INFO AND TO THE FACT THAT THE AFFECTED PRODUCT HAS NOT BEEN MADE AVAILABLE FOR INVESTIGATION THE COMPLAINT HAS BEEN CLOSED. THE REPORTED EVENT COULD NOT BE RETRACED.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRAGERSORB ABSORBENT CARBON DIOXIDE BSF DRAGER MEDICAL AG & CO. KG UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other