MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA PERSEUS A500; ANESTHESIA UNITS

Catalog Number MK06000

Device Problems Circuit Failure (1089); Gas Output Problem (1266); Failure to Deliver (2338)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/28/2023

Event Type  malfunction  

Event Description

It was reported that when pressure control ventilation was implemented a "turbovent2 failure" was displayed and only manual ventilation was possible.No injury reported.

Manufacturer Narrative

The investigation is still on-going.The results will be provided with a follow-up report.

Manufacturer Narrative

The affected perseus was requested for an in-depth investigation at manufacturing site but unfortunately has not arrived yet.Therefore, the analysis was performed based on the electronic log file.The entries indicate that the device passed the system test prior to the concerned procedure without deviations.Ventilation was unremarkable and stable for the first minutes until the supervisor function detected a failure in the motor control signal.Automatic ventilation was shut-down to protect the patient from potentially hazardous output.The user was alerted to this condition by means of a corresponding alarm.Monitoring functionalities and manual ventilation remain available in this case.The operator has continued to use the device for some minutes in manual ventilation, changed to standby and switched back to pressure control without further issues.Since neither the affected perseus nor replaced components were provided for investigation the root cause of the recurring error pattern reported with previous complaints could not be determined.The device has reacted as specified upon the detected deviation by shutting down automatic ventilation and posting a corresponding alarm to inform the user about the situation.

Event Description

It was reported that when pressure control ventilation was implemented a "turbovent2 failure" was displayed and only manual ventilation was possible.No injury reported.

• Brand Name: PERSEUS A500
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• Manufacturer Contact: moislinger allee 53-55; lübeck 23542 ; 4518822868
• MDR Report Key: 16830649
• MDR Text Key: 314169930
• Report Number: 9611500-2023-00155
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675253600
• UDI-Public: (01)04048675253600(11)170809(17)181004(93)MK06000-33
• Combination Product (y/n): N
• PMA/PMN Number: K133886
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 06/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MK06000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/29/2023
• Initial Date FDA Received: 04/28/2023
• Supplement Dates Manufacturer Received: 05/25/2023
• Supplement Dates FDA Received: 06/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1