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

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.

• Brand Name: AISYS CS2
• Type of Device: AISYS CS2
• Manufacturer (Section D): GENERAL ELECTRIC/ DATEX-OHMEDA, INC.
• MDR Report Key: 7057480
• MDR Text Key: 92986433
• Report Number: MW5073555
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• 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 Received: 11/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Disability
• Patient Age: 13 YR
• Patient Weight: 92