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

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.

• Brand Name: AISYS
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): DATEX-OHMEDA INC; 3030 ohmeda drive; madison WI 53718
• MDR Report Key: 9847537
• MDR Text Key: 183898282
• Report Number: 9847537
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/09/2019
• Date Report to Manufacturer: 03/18/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 21900 DA