MAUDE Adverse Event Report: DATEX-OHMEDA, INC. AISYS CS2; ANESTHESIA GAS MACHINE

Device Problem Improper Flow or Infusion (2954)

Patient Problem Awareness during Anaesthesia (1707)

Event Date 06/20/2016

Event Type  Injury  

Manufacturer Narrative

Ge healthcare's investigation into the reported occurrence is still ongoing.A follow-up report will be issued when the investigation has been completed.Medwatch mw5063850.The following information is not available because the reporter did not provide it on the medwatch and declined to be identified: patient information, initial reporter, date of manufacture.Ge healthcare's investigation into the reported occurrence is still ongoing.A follow-up report will be issued when the investigation has been completed.Medwatch mw5063850.The following information is not available because the reporter did not provide it on the medwatch and declined to be identified: patient information, initial reporter, date of manufacture.

Event Description

According to the user filed medwatch: "the event involves an anesthesia machine.The ge aisys cs2, which was introduced to our hospital mid (b)(6) 2016.The flowmeter digital field/dial is adjacent to the vaporizer digital field/dial.When using sevoflurane, both of these fields are yellow.In addition, typical air/o2/n2o flows are around "2" and the typical setting for sevoflurane is also around "2".The result is having two digital fields that are both yellow with similar numbers.We had an event where an anesthetist was intending to increase the vaporizer flow, but unintentionally increased the oxygen flow instead.This resulted in a period of unrecognized underdelivery of volatile anesthetic.Subsequently, the patient experiences awareness, in addition, it is required to confirm the previous vaporizer setting after replacing a cassette intraoperatively after 30 seconds.If not confirmed, there is a faint buzz - too soft to hear, and the vaporizer is automatically turned off.We have had incidences again where there was a period of time when we were unintentionally underdelivering volatile anesthetic, potentially resulting in awareness.We feel that the need to confirm the setting is redundant and dangerous intraoperatively (it should automatically go back to the last setting) and the alarm to indicate the vaporizer being turned off is too subtle.

Manufacturer Narrative

According to the user filed medwatch report, the customer stated: " air and sevoflurane controls use the same color scheme (yellow).The colors used for these gases is governed by international standards.All anesthesia systems in the united states complying with iso 80601-2-13 must use these colors." the clinician intended to increase the vaporizer flow, but unintentionally increased the oxygen flow.Required anesthetic agent gas monitoring displays fractionally inspired (fi) and end tidal (et) values for sevoflurane.User-set fi sevo low alarm limits will create a medium priority alarm if the fractionally inspired sevoflurane drops below desired values." the requirement to confirm settings is redundant.The design is such that, touchscreen ventilator and gas controls require a minimum of two actions to change settings.This mitigates the hazards associated with incorrect output or accidental selection of excessive output values.According to the user filed medwatch report, the customer stated: " air and sevoflurane controls use the same color scheme (yellow).The colors used for these gases is governed by international standards.All anesthesia systems in the united states complying with iso 80601-2-13 must use these colors." the clinician intended to increase the vaporizer flow, but unintentionally increased the oxygen flow.Required anesthetic agent gas monitoring displays fractionally inspired (fi) and end tidal (et) values for sevoflurane.User-set fi sevo low alarm limits will create a medium priority alarm if the fractionally inspired sevoflurane drops below desired values." the requirement to confirm settings is redundant.The design is such that, touchscreen ventilator and gas controls require a minimum of two actions to change settings.This mitigates the hazards associated with incorrect output or accidental selection of excessive output values.

• Brand Name: AISYS CS2
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda drive; madison WI 53718
• Manufacturer (Section G): DATEX-OHMEDA, INC.; 3030 ohmeda drive; madison WI
• Manufacturer Contact: john szalinski ; 540 w. northwest highway; barrington, IL 60010
• MDR Report Key: 5936391
• MDR Text Key: 54201870
• Report Number: 2112667-2016-01741
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K132530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 11/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/15/2016
• Initial Date FDA Received: 09/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/15/2016
• Date Device Manufactured: 01/01/1970
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other