MAUDE Adverse Event Report: GE HEALTHCARE AESTIVA 7900; ANESTHESIA MEDICINE

Model Number 7900

Device Problems Defective Device (2588); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 04/09/2016

Event Type  Injury  

Event Description

Machine passed fda checkout.Following induction and successful intubation, unable to ventilate patient.Several error messages received: vt compensation locked; inspiration stopped and cannot drive bellows.Machine removed from service and replaced with a properly functioning unit so that the surgical procedure could be completed.Upon examination by clinical engineering, unit was found to have a defective gas inlet valve.

• Brand Name: AESTIVA 7900
• Type of Device: ANESTHESIA MEDICINE
• Manufacturer (Section D): GE HEALTHCARE
• MDR Report Key: 5616227
• MDR Text Key: 43991426
• Report Number: MW5061954
• Device Sequence Number: 1
• Product Code: CAZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7900
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention