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

Catalog Number MK06000

Device Problems Gas Output Problem (1266); Inaccurate Delivery (2339)

Patient Problems Cardiac Arrest (1762); Respiratory Arrest (4461)

Event Date 03/23/2024

Event Type  Injury  

Manufacturer Narrative

The investigation is still on-going.The results will be provided with a follow-up report.H3 other text: on-going.

Event Description

It was reported about an incident with a perseus a500 in which the patient went into cardiorespiratory arrest.The anaesthesia device needed to be replaced to continue the operation.

Event Description

It was reported about an incident with a perseus a500 in which the patient went into cardiorespiratory arrest.The anaesthesia device needed to be replaced to continue the operation.

Manufacturer Narrative

The device log file was provided and analyzed.On the reported date of event, march 23rd 2024, the unit successfully passed the system test.The case in question was started at 10:55 using man/spont mode.At 10:56 an offset error of the differential pressure sensor pdmix was detected and a "fresh gas delivery failure" alarm was given.In this case of error all mixer relevant settings (fg o2, fg flow and carrier gas selection) on the gui (graphical user interface) will be covered by a message stating that gas delivery is stopped, and ventilation is still available.The virtual flow tubes are covered by a message explaining how to establish alternative fresh gas dosage using the safety o2 mechanism.By following these steps, the procedure can be continued with pure o2 fresh gas supply.It could be comprehended that the user opened the emergency o2 delivery valve.Nevertheless, a fresh gas deficit occurred in the following which was indicated by several "fresh gas low or leakage" and "emergency air inlet activated" alarms.According to the records, the fresh gas deficit was caused by an external leakage in the breathing circuit.At 11:32 the unit was placed in standby.Finally, it can be concluded that the observed fresh gas delivery failure was caused by a faulty differential pressure sensor.In consequence the electronical mixer was switched off autonomously and the corresponding alarm was posted.Ventilation can be continued in this state.Based on that fact a relation between this failure and the reported cardio respiratory arrest can be excluded.In the future course also a circuit leakage was present leading to a loss of pressure, volume and fresh gas.It is imagineable that ventilation was significantly restricted from this point on.The device behaved as specified for the detected situations by posting appropriate alarms.After replacement of the differential pressure sensor pdmix the device was successfully tested and was returned to use without further problems reported.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.The field failure rate is subject to permanent monitoring by the responsible product quality board and is rated as acceptable.

• 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: 19086134
• MDR Text Key: 339878840
• Report Number: 9611500-2024-00159
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675253600
• UDI-Public: (01)04048675253600(11)211203(17)220419(93)MK06000-40
• 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: 04/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 04/02/2024
• Initial Date FDA Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/03/2021
• 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
• Patient Outcome(s): Life Threatening