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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
Device Problems Computer Operating System Problem (2898); Therapeutic or Diagnostic Output Failure (3023)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/10/2019
Event Type  malfunction  
Event Description
A brand new anesthesia machine was put into electrophysiology procedure lab (aisys) to replace the old tiro this morning. The new machine failed in the middle of a sedation case during the afternoon. The top monitor with vs was still working, but i had no end tidal co2. All plugs were checked and were plugged in. Also, the machine was turned on and off and would not reboot. Biomed was called stat to the room and could not solve the problem. The patient was fine throughout, and we were able to finish the case. It would have been nice to have been able to monitor end tidal off of the lifepak but we did not have the correct adaptor needed to do so. End-tidal co2 was monitored with my hand (breathing) and o2 saturation (pulse ox of 100%) for the rest of the case. We decided not to change out the machine since we would have had to disconnect all of the monitors and would lose vital signs totally during that switch out. The subcutaneous implantable cardioverter-defibrillator was not tested during this anesthetic. We decided it would be too risky to induce ventricular fibrillation without the appropriate anesthesia equipment available (gas machine). The patient is scheduled to come back to have her defibrillator tested.
 
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Brand NameAISYS
Type of DeviceGAS-MACHINE, ANESTHESIA
Manufacturer (Section D)
DATEX-OHMEDA INC
3030 ohmeda drive
madison WI 53718
MDR Report Key9847537
MDR Text Key183898282
Report Number9847537
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 Other Health Care Professional
Type of Report Initial
Report Date 12/09/2019,12/06/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/18/2020
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/09/2019
Event Location No Information
Date Report to Manufacturer03/18/2020
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

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