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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATEX-OHMEDA, INC. AISYS; ANESTHESIA GAS MACHINE
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DATEX-OHMEDA, INC. AISYS; ANESTHESIA GAS MACHINE Back to Search Results
Device Problem Improper Flow or Infusion (2954)
Patient Problem High Blood Pressure/ Hypertension (1908)
Event Date 01/21/2022
Event Type  Injury  
Event Description
The hospital reported that when the device was switched to mechanical ventilation and end tidal control was selected, an error message appeared, and the screen went black.The patient was manually ventilated with good oxygenation.During manual ventilation, the anesthetic gas was delivered at the rate set before the screen went black causing the patient to receive a higher than desired amount anesthetic resulting in a drop in blood pressure that was raised by inotropy.
 
Manufacturer Narrative
Ge healthcare investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.No patient information provided to date.Legal manufacturer: (b)(4).No patient information provided to date.Legal manufacturer: (b)(4).
 
Manufacturer Narrative
Ge healthcare investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.No patient information provided to date.Legal manufacturer: (b)(4).No patient information provided to date.Legal manufacturer: (b)(4).
 
Event Description
The hospital reported that when the device was switched to mechanical ventilation and end tidal control was selected, an error message appeared, and the screen went black.The patient was manually ventilated with good oxygenation.During manual ventilation, the anesthetic gas was delivered at the rate set before the screen went black causing the patient to receive a higher than desired amount anesthetic resulting in a drop in blood pressure that was raised by inotropy.
 
Manufacturer Narrative
Based on the information provided in the complaint and the device logs, the root cause of the drop in the patients blood pressure was maintenance of the user anesthetic agent settings during a recourse and recovery event after a software watchdog failure, and an additional two minutes of anesthetic agent delivery at the same settings after functionality of the user interface was restored.The recourse & recovery (r&r) failure state for ge healthcare anesthesia devices allows a multi-processor device in a malfunction state to continue to mechanically ventilate a patient while the primary processor attempts to reboot (recover).Both during and after r&r event, the user could have removed the cassette at any point.Following the r&r event when the display was restored, the user had 2 minutes and 14 seconds to recognize that agent was still being delivered and turn it off while the display was functional.
 
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Brand Name
AISYS
Type of Device
ANESTHESIA GAS MACHINE
Manufacturer (Section D)
DATEX-OHMEDA, INC.
3030 ohmeda dr,
madison, WI 53718
Manufacturer (Section G)
DATEX-OHMEDA, INC.
3030 ohmeda dr,
madison, WI 53718
Manufacturer Contact
anthony amenson
3030 ohmeda drive
madison, WI 53718
MDR Report Key13552782
MDR Text Key285818264
Report Number2112667-2022-00305
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
K172045
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 05/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/17/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/15/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/26/2008
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage A
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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