MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC. PERSEUS A500; GAS-MACHINE, ANESTHESIA

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 03/29/2017

Event Type  malfunction  

Event Description

From the doctor: i was in an operating room for my first two cases.My third case was moved another operating room at the charge nurse's request.The anesthesia machine showed that it had completed a systems check without issues.I checked the integrity of the circuit anyway, which i always do for every case.I started the case and intubated the patient without incident, and then put the patient on volume control, which initially worked fine.About 20-30 minutes into the case, the ventilator started alarming for insufficient flow, and started delivering minimal tidal volumes (less than 50 ml), with minimal co2 return.I switched to 100% o2 and turned up my flows, and checked the integrity of all my connections, which appeared fine.I switched to manual ventilation and hand-bagged the patient, and was able to get normal volumes easily.I re-tried the volume control setting, which again was unable to deliver anything close to the specified tidal volume.I tried pressure control, which also did not work.Pressure support appeared to work at first, but subsequently failed.I called the anesthesia tech and she confirmed these findings, and was unable to find a cause.She switched out the co2 absorbent just in case, but this was normal and did not appear to be a factor, and made no difference.I did the rest of the case hand-bagging the patient until he was able to resume spontaneous ventilation.My conclusion is that there was an intrinsic leak or other failure in the machine's ventilator system during the case, which is a major safety issue.This same machine had a similar problem a couple of months ago with another anesthesiologist in the same room, resulting in a "near-miss" patient event (hypoxia and bradycardia).Two such instances with the same machine is particularly concerning, and needs to be resolved, as at some point it could easily cause serious harm to a patient.

• Brand Name: PERSEUS A500
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): DRAEGER MEDICAL SYSTEMS, INC.; 6 tech dr.; andover MA 01810
• MDR Report Key: 6516378
• MDR Text Key: 73520498
• Report Number: 6516378
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/11/2017
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/11/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/24/2017
• 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 Number: 1