MAUDE Adverse Event Report: GE HEALTHCARE / DATEX OHMEDA AESTIVA ANESTHESIA MACHINE

Model Number CS2

Device Problem Leak/Splash (1354)

Patient Problem Dizziness (2194)

Event Date 04/28/2017

Event Type  Injury  

Event Description

Crna smelled anesthesia gases and thought it was the pt's airway but could not find a leak.She became dizzy, and asked for another clinician to come into the room.The isoflurane vaporizer was leaking, vaporizer turned off.Anesthesia tech removed the vaporizer and placed a new one on the machine.After several minutes, the second vaporizer was noted to be leaking.Second clinician took over the case, first clinician put on oxygen by nasal cannula and called employee health, treated in the emergency room (er.) machine, vaporizers, and pt circuit removed and sent to biomed.Another machine was placed on pt.

• Brand Name: AESTIVA ANESTHESIA MACHINE
• Type of Device: ANESTHESIA MACHINE
• Manufacturer (Section D): GE HEALTHCARE / DATEX OHMEDA
• MDR Report Key: 6614341
• MDR Text Key: 76747715
• Report Number: MW5070188
• Device Sequence Number: 1
• Product Code: BSZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/05/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CS2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ISOFLURANE
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR