MAUDE Adverse Event Report: GE HEALTHCARE FINLAND OY ANESTHESIA MACHINE; GAS-MACHINE, ANESTHIA

Model Number 23862

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/12/2018

Event Type  malfunction  

Event Description

New ge anesthesia machine sn: (b)(4) showed the patient's etco2 to be 90 towards the end of the case.Anesthesia was able to confirm this was not the case after using a portable monitor.The case was completed.

• Brand Name: ANESTHESIA MACHINE
• Type of Device: GAS-MACHINE, ANESTHIA
• Manufacturer (Section D): GE HEALTHCARE FINLAND OY; 3000 n. grandview blvd; waukesha WI 53188
• MDR Report Key: 8174860
• MDR Text Key: 131135882
• Report Number: MW5082196
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• 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: 12/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 23862
• 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
• Patient Age: 70 YR