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U.S. Department of Health and Human Services

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

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DATEX-OHMEDA INC AESTIVA GAS-MACHINE, ANESTHESIA Back to Search Results
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.

 
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Brand NameAESTIVA
Type of DeviceGAS-MACHINE, ANESTHESIA
Manufacturer (Section D)
DATEX-OHMEDA INC
3030 ohmeda drive
madison WI 53718
MDR Report Key11036293
MDR Text Key222312447
Report Number11036293
Device Sequence Number1
Product Code BSZ
Combination Product (Y/N)N
Number of Events Reported1
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 Received12/18/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number7900
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/10/2020
Event Location Hospital
Date Report TO Manufacturer12/18/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 12/18/2020 Patient Sequence Number: 1
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