• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE HEALTHCARE / DATEX OHMEDA AESTIVA ANESTHESIA MACHINE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

GE HEALTHCARE / DATEX OHMEDA AESTIVA ANESTHESIA MACHINE Back to Search Results
Model Number CS2
Device Problem Leak/Splash (1354)
Patient Problem Dizziness (2194)
Event Date 04/28/2017
Event Type  Injury  
Event Description
Crna smelled anesthesia gases and thought it was the pt's airway but could not find a leak. She became dizzy, and asked for another clinician to come into the room. The isoflurane vaporizer was leaking, vaporizer turned off. Anesthesia tech removed the vaporizer and placed a new one on the machine. After several minutes, the second vaporizer was noted to be leaking. Second clinician took over the case, first clinician put on oxygen by nasal cannula and called employee health, treated in the emergency room (er. ) machine, vaporizers, and pt circuit removed and sent to biomed. Another machine was placed on pt.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameAESTIVA ANESTHESIA MACHINE
Type of DeviceANESTHESIA MACHINE
Manufacturer (Section D)
GE HEALTHCARE / DATEX OHMEDA
MDR Report Key6614341
MDR Text Key76747715
Report NumberMW5070188
Device Sequence Number1
Product Code BSZ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 06/05/2017
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received06/05/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCS2
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 06/05/2017 Patient Sequence Number: 1
Treatment
ISOFLURANE
-
-