MAUDE Adverse Event Report: DATEX OHMEDA GE AESTIVA/5; GAS-MACHINE, ANESTHESIA

Model Number 7900 CON

Device Problems Fluid/Blood Leak (1250); Tidal Volume Fluctuations (1634)

Patient Problem No Information (3190)

Event Date 07/24/2014

Event Type  malfunction  

Event Description

The anesthesia machine initially seemed as though there was a leak which produced inadequate tidal volume.Crna stated she turned the flows up to compensate for this leak and the end expiratory pressures began climbing.Upon further exam the vent pressures were also climbing.The patient was removed from the vent and was hand ventilated via an ambu bag for the remainder of the case.The patient was also placed on a propofol infusion during this time.The machine was tagged and the room was also tagged as being out of service.No previous indications that there was a problem with the machine.Device passed all checks prior to procedure start.

• Brand Name: GE AESTIVA/5
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): DATEX OHMEDA; 3030 ohmeda dr; madison WI 53718
• MDR Report Key: 3972672
• MDR Text Key: 4636616
• Report Number: 3972672
• Device Sequence Number: 1
• Product Code: BSZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7900 CON
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/26/2014
• Device Age: 10 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/01/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 84