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

Model Number MK06000

Device Problems Circuit Failure (1089); Gas Output Problem (1266); Failure to Deliver (2338); Electrical Overstress (2924)

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

Event Date 04/28/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation was just started.The result will be forwarded once the investigation is closed.

Event Description

It was reported that there was a noise during ventilation.After a while alarm "turbo vent 2 defect" message occurred and device had shut down.No injury reported.

Manufacturer Narrative

The log file was analyzed and the returned parts were inspected and tested.It was found that due to a faulty calibration valve a part at the pba blower was burnt.As reported the device alarmed with turbovent 2 failure and performed a reboot of the therapy control unit m16.2.The device was operated in manual ventilation mode afterwards.In case of a reboot of the therapy control unit m16.2 the therapy is discontinued for a maximum of 15 seconds, before therapy will be resumed with the latest valid settings.If for any reasons therapy was not restarted within 15 seconds an acoustical alarm will be given.Manual ventilation remains possible.It was concluded that the device behaved as specified for this failure condition.Since no comparable cases are known the case is assessed as an isolated failure.

Event Description

It was reported that there was a noise during ventilation.After a while alarm "turbo vent 2 defect" message occurred and device had shut down.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: 14406917
• MDR Text Key: 297588070
• Report Number: 9611500-2022-00117
• 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: 07/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MK06000
• Device Catalogue Number: MK06000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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