MAUDE Adverse Event Report: DATEX-OHMEDA, INC. CARESTATION 650; ANESTHESIA GAS MACHINE

Model Number 1012-9650-000

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Death (1802)

Event Date 05/17/2019

Event Type  Death  

Manufacturer Narrative

Ge healthcare's investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.(b)(4).Report source other: medwatch mw5087239.Per customer description of event in medwatch mw5087239: "a (b) (6) y/o male pt with a complex medical history underwent a right sided fistulogram.He was given supplemental oxygen via mask.Immediately prior to the start of the procedure, there was a handoff of care between anesthesiologists.The pt was awake at this time.Intravenous medications were administered.Following this, the pt experienced a short period of respiratory distress.An oral airway was placed and mask ventilation was initiated.It was at this point, the anesthesiologist discovered the oxygen delivered through the carestation machine had been set to the bag/ventilator setting rather than the auxiliary/mask setting.He immediately switched the dial in the machine to the correct setting.An lma was placed and the pt was placed on pressure support ventilation.While the pt's oxygen saturation improved, he remained unresponsive following the procedure.During the investigation into this matter, it was discovered in most anesthesia machines, oxygen intended to be delivered via circuit (bag, ventilator) is completely separated from oxygen administered through the auxiliary mode (nasal or mask), with independent flow meters that are not shared so as not to lead one to believe oxygen is being delivered via auxiliary when it is not.Device evaluation anticipated, but not yet begun.

Event Description

The hospital reported a patient death allegedly resulting from a design defect in the carestation 650 anesthesia machine.

Manufacturer Narrative

The aux o2+air feature was tested during carestation 600 series development phase in year 2015 in a summative usability test and the system passed.The design is correct and efficient for the user to access this feature.Ge healthcare product engineering performed an investigation of this event.Two use workflows were simulated.Workflow1: use of the aux o2+air function with reading the manual; workflow 2: use of the aux o2+air function without reading the manual.The system was installed in the customer site over 2.5 years and based on the above two workflows, a user with good clinical practice should have enough knowledge to know how to correctly use the function of aux o2+air.The user did not set the aux o2+air switch to aux o2+air position while connecting a mask to aux o2+air port to give supplemental oxygen to the patient.The historic usability study in combination with the engineering analysis of two workflows, led us to conclude that the device can be used as specified whether or not the instructions are read prior to use.Therefore, the root cause of this case is user error.H3 other text : the aux o2+air feature was tested during carestation 600 series development phase in year 2015 in a summative usability test and the system passed.The design is correct and efficient for the user to access this feature.Ge healthcare product engineering performed an investigation of this event.Two use workflows were simulated.Workflow1: use of the aux o2+air function with reading the manual; workflow 2: use of the aux o2+air function without reading the manual.The system was installed in the customer site over 2.5 years and based on the above two workflows, a user with good clinical practice should have enough knowledge to know how to correctly use the function of aux o2+air.The user did not set the aux o2+air switch to aux o2+air position while connecting a mask to aux o2+air port to give supplemental oxygen to the patient.The historic usability study in combination with the engineering analysis of two workflows, led us to conclude that the device can be used as specified whether or not the instructions are read prior to use.Therefore, the root cause of this case is user error.

• Brand Name: CARESTATION 650
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• MDR Report Key: 8767189
• MDR Text Key: 150254690
• Report Number: 2112667-2019-00216
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K151570
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 12/05/2019

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
• Device Model Number: 1012-9650-000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/11/2019
• Initial Date FDA Received: 07/08/2019
• Supplement Dates Manufacturer Received: 11/07/2019
• Supplement Dates FDA Received: 12/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 70 YR
• Patient Weight: 77