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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATEX-OHMEDA INC AISYS; GAS-MACHINE, ANESTHESIA
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DATEX-OHMEDA INC AISYS; GAS-MACHINE, ANESTHESIA Back to Search Results
Model Number CS2
Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/02/2018
Event Type  malfunction  
Event Description
Patient intubated at 1044 and while flipping patient to prone position, ventilator and screen of anesthesia machine failed.Screen stated: "internal problem prevents normal operation 1.Set o2 flow with knob 2.Manually ventilate.To restart, turn power off and on." anesthesia tech was called stat to room.Machine turned off and on several times and error did not clear.Pt was bagged and there was no harm to the patient.Manufacturer response for aisys ventillator / anesthesia machine, aisys (per site reporter).Manufacturer service engineer evaluated device at hospital facility.
 
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Brand Name
AISYS
Type of Device
GAS-MACHINE, ANESTHESIA
Manufacturer (Section D)
DATEX-OHMEDA INC
3030 ohmeda drive
madison WI 53718
MDR Report Key7388031
MDR Text Key104039702
Report Number7388031
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 03/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberCS2
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/23/2018
Device Age11 YR
Event Location Hospital
Date Report to Manufacturer03/23/2018
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/02/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
NO OTHER THERAPIES; UNKNOWN?, PATIENT WAS IN THE OR UNDER GENERAL ANES
Patient Age20 YR
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