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

Catalog Number MK06000

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

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

Event Date 01/20/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is still on-going.The results will be provided with a follow-up report.

Event Description

It was reported that during use of the anesthesia machine a "turbovent2" failure alarm occurred.By activating add o2 and change to emergency oxygen supply mode the case was continued.No injury reported.

Event Description

It was reported that during use of the anesthesia machine a "turbovent2" failure alarm occurred.By activating add o2 and change to emergency oxygen supply mode the case was continued.No injury reported.

Manufacturer Narrative

Based on the device log analysis the reported "turbovent2" failure could be confirmed.The case in question was started at 09:06 using man/spont and was continued in pressure control.The following ventilation was unremarkable until a "turbovent 2 failure" alarm was posted at 16:13 and a reboot of the therapy control unit m16.2 was performed.As after the reboot the blower failure persisted a corresponding alarm was generated and the device notified the user to continue ventilation with man/spont mode.The patient was manually ventilated until 20:14 when the unit was placed in standby.The pba blower a500 and the calibration valve were provided for investigation.A visual inspection of the pba revealed a burned transistor v5 which is part of the calibration valve control.The calibration valve was found to be undamaged and was assembled into a laboratory device.It was found that when switching the valve to the open position the same transistor v5 of the laboratory device also got burned.Therefore, it can be concluded that a faulty calibration valve has led to an overload of the transistor v5 resulting in a non-functional valve and finally caused the reboot of the therapy control unit m16.2.The device has behaved as specified for the detected failure condition.The faulty components have already been replaced.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
• Manufacturer Contact: moislinger allee 53-55; lübeck 23542 ; 4518822868
• MDR Report Key: 16373620
• MDR Text Key: 309512729
• Report Number: 9611500-2023-00061
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675253600
• UDI-Public: (01)04048675253600(11)210714(17)220221(93)MK06000-39
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 01/23/2023
• Initial Date FDA Received: 02/14/2023
• Supplement Dates Manufacturer Received: 03/17/2023
• Supplement Dates FDA Received: 03/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2021
• 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