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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENERAL ELECTRIC/ DATEX-OHMEDA, INC. AISYS CS2

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GENERAL ELECTRIC/ DATEX-OHMEDA, INC. AISYS CS2 Back to Search Results
Device Problem Device Alarm System (1012)
Patient Problems Low Oxygen Saturation (2477); Sleep Dysfunction (2517)
Event Date 10/26/2017
Event Type  Injury  
Event Description
A (b)(6) female with chief complaint of poor sleep, excessive snoring and frequent awakenings was scheduled for adenotonsillectomy under general anesthesia. The patient desaturated with induction of anesthesia, and the surgical procedure was aborted with the patient subsequently transferred to an outside facility for continued care. The inspiratory limb of the aisys cs2 was noted to have the low pressure check, double-ended stopper in place, resulting in the patient not receiving oxygen. There are potentially multiple design issues related to optional low peak pressure testing. There is a lock-out safety feature on the anesthesia machine that prevents any further use of the machine once the low pressure check is started. If the rubber stopper is placed, but the test is not started, no alarm fires and no lock-out occurs. Further, regardless of the initiation of the low pressure test, the circuit does not alarm if the inspiratory limb is occluded. Additionally, the alarms on the anesthesia machine are not specific to a machine/ circuit issue and could be attributed to patient condition. The design should consider incorporating variations in the sound and length of alarms to indicate the issue stems from the anesthesia circuit, rather than the patient's condition. Moreover, the aisys cs2 includes two low pressure stoppers, a flat backed stopper and a double-ended stopper that perfectly fits the inspiratory limb of an anesthesia circuit onto it, which fully occludes the circuit and prevents delivery of any gas flow. Finally, buyers of the equipment since the last fda review of this machine may not be adequately aware or warned of these design challenges which lack maximum system safeguards to best support providers delivering complex surgical anesthesia services.
 
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Brand NameAISYS CS2
Type of DeviceAISYS CS2
Manufacturer (Section D)
GENERAL ELECTRIC/ DATEX-OHMEDA, INC.
MDR Report Key7057480
MDR Text Key92986433
Report NumberMW5073555
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 11/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/24/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 11/24/2017 Patient Sequence Number: 1
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