MAUDE Adverse Event Report: DATEX-OHMEDA INC AESTIVA; GAS-MACHINE, ANESTHESIA

Model Number 7900

Device Problems Break (1069); Physical Resistance/Sticking (4012)

Patient Problems Cardiopulmonary Arrest (1765); Cardiac Tamponade (2226)

Event Date 12/09/2020

Event Type  Injury  

Event Description

Ventilator in the operating room has problem with exploratory valve being stuck closed at beginning of case.They thought they fixed it, but it broke again at end of case.Patient ended up coding, had chest reopened and needed to crash back on bypass.Patient is now in icu.The code was related to the expiration valve on the vent.The lungs over distended because the expiratory valve was stuck shut.This increased the intrathoracic pressure, essentially creating tamponade and causing the patient to code.His chest was quickly opened, and he had about 3 minutes of cpr.He did require re-initiation of cardiopulmonary bypass but was able to wean and have his chest closed.

• Brand Name: AESTIVA
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): DATEX-OHMEDA INC; 3030 ohmeda drive; madison WI 53718
• MDR Report Key: 11036293
• MDR Text Key: 222312447
• Report Number: 11036293
• 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: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7900
• 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: 12/10/2020
• Event Location: Hospital
• Date Report to Manufacturer: 12/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 23360 DA
• Patient Weight: 114