MAUDE Adverse Event Report: GE HEALTHCARE, INC GE ADVANCE CS2; GAS-MACHINE, ANESTHESIA

Model Number CS2

Device Problem Loss of Power (1475)

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

Event Date 06/04/2019

Event Type  malfunction  

Event Description

During surgery, the anesthesia machine shutdown unexpectedly.The anesthesia group quickly had the patient ventilating with an ambu bag and oxygen tank.Hooked patient up to transport monitor for vitals.Machine swapped out to a different anesthesia machine that was working appropriately.Approximately 25 minutes all together.Patient remained stable with vitals never changing.

• Brand Name: GE ADVANCE CS2
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): GE HEALTHCARE, INC; 3000 n grandview blvd; w-450; waukesha WI 53188
• MDR Report Key: 8711751
• MDR Text Key: 148450412
• Report Number: 8711751
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2019
• 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?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/06/2019
• Event Location: Hospital
• Date Report to Manufacturer: 06/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 17885 DA