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 11/14/2022

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.

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.

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 failure could be traced back to a singular outage of the pcb a500 blower.After the user restarted the unit and performed a system test the case was continued without further issues.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.

• 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: 15975228
• MDR Text Key: 306206173
• Report Number: 9611500-2022-00340
• 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: 01/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2022
• 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: 01/12/2023
• 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