BEUDAMED
    FDA Adverse Event Other Summary report: N

    AISYS

    MDR report key: 1040656 · Received May 6, 2008

    Report

    Report Number
    2112667-2008-00017
    Event Type
    Other
    Date Received
    May 6, 2008
    Date of Event
    April 4, 2008
    Report Date
    May 6, 2008
    Manufacturer
    DATEX-OHMEDA
    Product Code
    BSZ
    PMA / PMN Number
    K042154
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY DID NOT INSTALL THE ABSORBER PRIOR TO THE START OF THE CASE, RESULTING IN A SIZEABLE LEAK. THE LEAK AFFECTED THE ABILITY TO SUFFICIENTLY VENTILATE THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY. INVESTIGATION/CONCLUSION: A PREOPERATIVE CHECK OF THE EQUIPMENT, SUCH AS THE FDA CHECKOUT RECOMMENDATIONS OR AS STATED IN THE (B) (4) USER REFERENCE MANUAL, IS DESIGNED TO PICK UP SUCH A CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AISYS ANESTHESIA MACHINE BSZ DATEX-OHMEDA

    Patients

    Seq Age Sex Outcome Treatment
    1