MAUDE Adverse Event Report: GE HEALTHCARE AESTIVA; GAS-MACHINE, ANESTHESIA

Model Number 1006-9305-000

Device Problem Loss of Power (1475)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/24/2018

Event Type  malfunction  

Event Description

Patient was on or table and intubated and on volume control.Anesthesia monitor was working appropriately when the anesthesia machine monitor loss the peep and ie reading.There was no flicker or glitch in the screen.It appeared as if the readings were shut off.Pt.Bagged while anesthesia machine was switched out and taken out of service to bio-med.No pt.Harm.Bio-med contacted ge for assistance.Problem could not be duplicated.

• Brand Name: AESTIVA
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): GE HEALTHCARE; 8200 w tower ave; milwaukee WI 53223
• MDR Report Key: 7836593
• MDR Text Key: 118880010
• Report Number: 7836593
• 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: 08/27/2018,08/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1006-9305-000
• 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: 08/27/2018
• Date Report to Manufacturer: 08/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 11315 DA