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

Model Number AVANCE CS2

Device Problem Obstruction of Flow (2423)

Patient Problem Death (1802)

Event Date 01/05/2016

Event Type  Death  

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.Device evaluation anticipated, but not yet begun.

Event Description

Per the user filed medwatch report: "the anesthesiologist was asked to anesthetize the patient.During intubation, the patient became hypoxic.Ventilation was difficult and there was ongoing bradycardia and hypertension.It was noted that the co2 waveform was flat and not correlating with ventilation breaths or compressions.Severe ventilation effort was noted and correct ett placement was verified with fluoroscopy.The required ventilation effort caused the ventilation bag to rupture.During replacement of the ventilation bag, other circuit connections were checked, and a rubber test stopper was found occluding the output port of the anesthesia machine.The stopper was removed and the patient was reintubated.Ventilation normalized and skin color improved." it was further reported by the hospital that, at some point later, the patient reportedly coded, was removed from life support, and died.

Manufacturer Narrative

It was reported to ge healthcare that a test plug was inserted into the inspiratory port of the machine during the preoperative checkout and not removed prior to the start of the case.Once difficulty in ventilation was noted during the case, another anesthesiologist was reportedly called to assist and noted the test plug.Once the plug was removed, flow to the patient was restored.The logs were downloaded and provided to the manufacturing site for analysis.The logs indicate numerous alarms occurred, indicating the patient was not receiving appropriate ventilation.

• Brand Name: AVANCE 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 53718
• Manufacturer Contact: john szalinski ; 540 w. northwest highway; barrington, IL 60010
• MDR Report Key: 5396487
• MDR Text Key: 37014646
• Report Number: 2112667-2016-00157
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 04/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AVANCE CS2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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): Death
• Patient Age: 88 YR