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

Model Number PERSEUS A500

Device Problems Display or Visual Feedback Problem (1184); Use of Device Problem (1670); Therapeutic or Diagnostic Output Failure (3023); Unexpected Shutdown (4019)

Patient Problem Insufficient Information (4580)

Event Date 02/15/2021

Event Type  malfunction  

Event Description

Anesthesia machine completely turned off for a second, then flashed red and said, "ventilator failure".Crna began manually ventilating the patient.Within 10 seconds, the machine turned back on and the ventilator was working again.The surgery was finished without future incident, and then machine was removed from service.No harm to patient.Biomed notified.Routine machine check was conducted and passed early this morning, prior to being used.Manufacturer response for anesthesia, delivery unit, with monitor:, draeger (per site reporter): unit gave the errors and flickered.The errors only lasted for a few seconds then went away.They were able to finish the case with no issues.They were using fluoroscopy at the time of the errors.They thought it may have been a power issue.The unit was pulled out of service.I downloaded the logs to keep and view.I performed a patient simulation for 30 min, with no issues.I sent the logs to draeger for review and reported it as a patient incident.I spoke to the tech on call.He could not give me a case number due to a software upgrade during the holiday.I have attached the logs also.We will put the unit on hold until i hear back from draeger.We received the log results back from draeger.They recommend to reset the m16 board and wipe the cf card.Reset to factory settings.I called the unit in for tech service to perform the work.We wiped and replaced software on the m16 board and wiped the cf card and re-flashed it and installed the proper gas colors and site settings.Performed a full function system test and passed.The unit was returned to service.

• Brand Name: PERSEUS A500
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; 3135 quarry rd; telford PA 18969
• MDR Report Key: 11626938
• MDR Text Key: 244179733
• Report Number: 11626938
• 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: 03/15/2021,02/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2021
• 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: 03/15/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1