BEUDAMED
    FDA Adverse Event Other Summary report: N

    AISYS

    MDR report key: 1172779 · Received September 18, 2008

    Report

    Report Number
    2112667-2008-00038
    Event Type
    Other
    Date Received
    September 18, 2008
    Date of Event
    August 1, 2008
    Report Date
    September 18, 2008
    Manufacturer
    DATEX-OHMEDA
    Product Code
    BSZ
    PMA / PMN Number
    K042154
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT IS AN ESTIMATE. ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION, E.G. SERIAL #, EXACT DATE OF EVENT, PATIENT INFORMATION, ETC., HOWEVER, NO INFORMATION, TO DATE, HAS BEEN RECEIVED. INVESTIGATION/CONCLUSION: THE (B) (4) USERS MANUAL, PREOPERATIVE TESTS SECTION, STEP 1 OF THE LOW PRESSURE LEAK CHECK STATES, "OCCLUDE THE INSPIRATORY (RIGHT-HAND) PORT". ONCE THE TEST IS COMPLETED, THE MANUAL STATES THAT THE USER IS TO "OPEN THE INSPIRATORY PORT AND RECONNECT THE BREATHING CIRCUIT".

    Description of Event or Problem · 1

    THE CUSTOMER PROVIDED THE FOLLOWING TIMELINE OF EVENTS: ORANGE TEST PLUG PLACED IN INSPIRATORY PORT FOR ROUTINE LOW PRESSURE LEAK TEST, AS STATED IN PREOPERATIVE TESTS CONTAINED IN THE (B) (4) USER MANUAL. RESPIRATORY THERAPIST LEFT ROOM WHILE TEST WAS IN PROCESS. STUDENT ENTERED ROOM AND SAW CIRCUIT TUBING DANGLING FROM MACHINE AND ATTACHED IT TO THE END OF THE ORANGE TEST PLUG. NO MANUAL PRESSURE TEST DONE PRIOR TO PROCEDURE. PATIENT'S PRE-OXYGENATION SATS ROSE, ETC02 REGISTERED ON MONITOR. LACK OF EXPIRED OXYGEN READING WAS MISSED AS WAS THE LACK OF INFLATION AND DEFLATION OF THE RESERVOIR BAG. PATIENT CODED. MACHINE CHECKED AND CIRCUIT TUBING HOOKED UP CORRECTLY. THERE WAS NO REPORTED PATIENT INJURY.

    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 20 YR