MAUDE Adverse Event Report: DATEX-OHMEDA AISYS; ANESTHESIA GAS MACHINE

Device Problem Misconnection (1399)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 05/09/2014

Event Type  Injury  

Event Description

According to the received medwatch report: "once patient intubated, the positive and expiratory pressure (peep) was measuring 10 cm.The anesthesia machine peep was set at 0 cm (zero), with peep measuring 10 cm.The machine was then turned off, and the patient was ventilated by hand with an ambu bag with 100% oxygen.The lungs were determined to be clear but the patient's heart rate (svt) was 140 bpm, they were also hypotensive.Contact was made immediately to ge healthcare rep transferred to the operating room troubleshoot on (b)(6) 2014.Contacted ge tech support and transferred them to the operating room to troubleshoot from there.By the time we got into the room the case had been canceled and the patient was off the table.Tech support walked me through trouble shooting the evac system which led to the evac line wall connection.Evac appeared to be connected but upon checking the seating, the connection clicked.Followed ge tech support steps to test the system in auto mode with a test lung.With 2 lpm o2 flow and peep off, the peep was within the normal range at 2 cmh2o.When the eval line is not connected, the gases that are supposed to be removed will built up in bag under the unit.This bag takes a long time to fill.Once the bag is filled, it will create a back pressure in the circuit.This is why the peep was measuring 10.After finding the evac hose not fully connected to the wall outlet.The biomed tech pressed on it and it locked in, denoted by the click.The gases were evacuated and the peep measured correctly.There is no alarm to give warning or alert." the hospital reported the patient's blood pressure was in the normal range on arrival in the operating room.Following the reported event, the patient was treated with phenylephrine for low blood pressure, and esmolol for the svt issue.Surgery had not started, the case was canceled, and the patient was discharged.The patient had the surgery on a later date, and it was reportedly completed with no complications.

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.

• Brand Name: AISYS
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): DATEX-OHMEDA; madison WI
• Manufacturer (Section G): DATEX-OHMEDA INC.,; madison WI
• Manufacturer Contact: john szalinski ; 540 w. northwest highway; barrington, IL 60010-3076 ; 8472774719
• MDR Report Key: 3946665
• MDR Text Key: 16856344
• Report Number: 2112667-2014-00087
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042154
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 05/09/2014

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/18/2014
• Initial Date FDA Received: 07/07/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 65