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 Insufficient Information (4580)

Event Date 10/26/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during use, a ¿turbovent2 failure" was displayed and ventilation stopped.After restarting the device, it recovered.There was no patient injury reported.Same failure for identical device has been reported before (date of emdr on 2022-12-14 under mdr report no.9611500-2022-00340) for date of event on (b)(6) 2022.However, it was found that the same issue occurred on (b)(6) 2022 as well.It could not be excluded that a patient was involved during that case leading to this separate report for the issue on (b)(6) 2022.

Manufacturer Narrative

The device log file analysis revealed that on the reported date of event a signal failure of the control responsible for the motor speed and motor direction occurred.The signal was not transmitted correctly leading to the reported turbo vent 2 failure.The device has reacted on the detected deviation as specified by posting a corresponding alarm.In this case automatic ventilation is no longer possible.Fresh gas and manual ventilation remain available.The sporadic failure could be traced back to a faulty component onboard the pcb a500 blower.The field-failure-rate of the pcb a500 blower is accepted by the responsible product quality board.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 during use, a ¿turbovent2 failure" was displayed and ventilation stopped.After restarting the device, it recovered.There was no patient injury reported.Same failure for identical device has been reported before (date of emdr on (b)(6) 2022 under mdr report no.9611500-2022-00340) for date of event 2022-11-14.However, it was found that the same issue occurred on (b)(6) 2022 as well.It could not be excluded that a patient was involved during that case leading to this separate report for the issue on (b)(6) 2022.

• 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: 15986075
• MDR Text Key: 308196224
• Report Number: 9611500-2022-00343
• 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: 02/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2022
• 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: 02/14/2023
• 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