MAUDE Adverse Event Report: DRAEGERWERK AG & CO. KGAA PERSEUS A500; GAS-MACHINE, ANESTHESIA

Model Number PERSEUS A500

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Insufficient Information (4580)

Event Date 06/16/2021

Event Type  malfunction  

Event Description

Gas machine malfunction recognized by anesthesia care team during procedure.Etco2 falsely low.Anesthetic gas and fresh gas delivery compromised.We quickly transitioned to a total intravenous anesthetic (tiva).Manual ventilation assumed.Bis monitoring added to assess depth of anesthesia.Patient vitals signs stable.Patient remained at adequate depth of anesthesia throughout case with transition to tiva.Machine removed for service immediately following procedure.Manufacturer response for anesthesia delivery unit, (brand not provided) (per site reporter) went up to the case, sevo was set at 3 and only reading 1.Had them swap the sevo and we had the same results.Tried going to des and put at 10, took a while to begin reading desflurane and finally it was reading only about 3.1 max.Had the change out the mask filter, this did not make a difference.It was suggested to make sure the water trap was seeded all the way in.Staff assured me he did that and also changed the water trap with the same results.Had him pull the machine and keep all the patients ckts etc.Had to go to south campus to pick up our perseus kit with computer and kits for testing this unit.Staff called and the machine was ready for us to pick up.Brought down to the shop and hooked up and begin running the system test with the original patients ckts and the water trap he had already changed out.Assists with anesthesia machine.Unit passed system test.We hooked up the water trap and saw we only had a flow of 50 ml max.(this should be 180-220ml).We called dragger tech support and described the problem.They pointed us to something in the water trap area.We removed the water trap and set it back in but it still had a 50 ml flow.We pushed down on the water trap holder and the reading came right back up to 192ml where they should be.On further investigation it was determined that the water trap holder had a screw holding it to the bulk head and it was lose.We tightened the holder and snapped in the water trap.All the flow was great, when we tried to move the water trap it stayed solid, about 194ml flow.Tested the sevo and desflurane readings and they came up quickly and were reading what the settings were on the vaporizers.Called staff down and he came to see what we found and he also was confident we identified and fixed the problem.Called dragger back and let them know what we had found, told them to let the field service people know that if they see this problem that the water trap holder being lose could be the problem.They agreed that this was the problem that was causing our problems and that the issue was resolved.Tech support agreed that it was ok to return this unit to use , as the problem had been identified and repaired.Talked with staff and we returned the device back up to surgery for use.

• Brand Name: PERSEUS A500
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): DRAEGERWERK AG & CO. KGAA; 3135 quarry rd; telford PA 18969
• MDR Report Key: 12252125
• MDR Text Key: 264328977
• Report Number: 12252125
• 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: 06/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: PERSEUS A500
• 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: 06/18/2021
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 15330 DA