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 12/09/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation has just started; results will be provided in a follow-up report.Investigation on-going.

Event Description

It was reported that on (b)(6) 2022 a turbovent2 failure occurred during a surgery, after restarting the device, electric system became unfunctional and start button could not be pushed.Anesthetist requested to continue to use the device with manual ventilation.After restarting the device twice, man/spont button became functional, so continued to use it for the surgery.No injury reported.

Manufacturer Narrative

Device and log file were evaluated by an engineer of the local s&s organization.The analysis revealed that on the reported date of event a signal failure onboard the pcb which controls the motor speed and motor direction has occurred.The signal was not transmitted correctly leading to the reported turbo vent failure.In this case automatic ventilation is no longer possible.Fresh gas and manual ventilation remain available.The suspected blower pcb was provided to the manufacturer for investigation and was assembled in a lab device.The reported symptom could be reproduced and, the blower control pcb was found to be faulty.A detailed investigation of the board revealed a faulty digital isolator to be root cause.Replacement of the respective pcb has solved the issue.The device was tested and was returned to use without further problems reported to date.Review of similar complaints received in the past revealed that this specific device failed the second time due to this failure mechanism.The particular subsystem of the motor control unit is used in unchanged design since market introduction in 2012; post market surveillance data reasonably suggest that no issue of systemic nature is present.Dräger finally concludes that the device has reacted on the detected deviation as specified by posting a corresponding alarm.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.

Event Description

It was reported that on (b)(6) 2022, a turbovent2 failure occurred during a surgery, after restarting the device, electric system became unfunctional and start button could not be pushed.Anesthetist requested to continue to use the device with manual ventilation.After restarting the device twice, man/spont button became functional, so continued to use it for the surgery.No injury reported.

• Brand Name: PERSEUS A500
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck ; GM
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 16003510
• MDR Text Key: 305720014
• Report Number: 9611500-2022-00344
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675253600
• UDI-Public: (01)04048675253600(11)170906(17)180419(93)MK06000-34
• 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: 02/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2022
• 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
• Date Manufacturer Received: 01/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2017
• 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