MAUDE Adverse Event Report: DATEX OHMEDA (GE) AESTIVA 5/7900; AESTIVA ANESTHESIA MACHINE

Device Problems False Alarm (1013); Leak/Splash (1354)

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

Event Date 10/08/2019

Event Type  malfunction  

Event Description

During laparoscopic cholecystectomy, low concentration notification appeared on monitor of anesthesia machine.Pt woke up during closing despite the high concentration of sevoflurane.Add'l anesthesia immediately provided via iv.Vaporizer involved: tec 7 (sevo) serial # (b)(4), datex ohmeda (division of gh healthcare).A leak was found at the connection to the sodasorb canister.

• Brand Name: AESTIVA 5/7900
• Type of Device: AESTIVA ANESTHESIA MACHINE
• Manufacturer (Section D): DATEX OHMEDA (GE) ; 3000 n grandview blvd; waukesha WI
• MDR Report Key: 9252402
• MDR Text Key: 164668357
• Report Number: 9252402
• 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: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/08/2019
• Event Location: Hospital
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 33 YR