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 05/05/2022

Event Type  malfunction  

Manufacturer Narrative

Other than initially described it was found during the course of the logfile analysis that the device failed during operation.The logfile analysis showed that the case in question was started and ventilation was unremarkable.After some time of ventilation a control signal failure was detected and a turbo vent 2 failure alarm was given.The user continued ventilation using man/spont before putting the device into standby.The turbovent 2 (blower) generates the preset airway pressure.In the case of a turbovent2 failure automatic ventilation is no longer possible and the corresponding alarm is given.Fresh gas dosage and manual ventilation remains available.The exact root cause couldn¿t be determined as the replaced hardware was not available for an in-depth analysis.However the problem was most likely caused by a faulty pba component.Since replacement oft he pba has fixed the problem it was concluded that the root cause was located onboard that pba.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 the main driver board of the perseus was replaced due to a turbovent failure.No specific case with patient involvement was 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: 16384340
• MDR Text Key: 309639150
• Report Number: 9611500-2023-00063
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675253600
• UDI-Public: (01)04048675253600(11)170426(17)180203(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
• Report Date: 02/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2023
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2017
• 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