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

Catalog Number MK06000

Device Problems Decrease in Pressure (1490); Inaccurate Delivery (2339); Gas/Air Leak (2946)

Patient Problem Insufficient Information (4580)

Event Date 02/26/2024

Event Type  Death  

Manufacturer Narrative

The investigation has just started; results will be provided in a follow-up report.H3 other text : on-going.

Event Description

It was reported that a seriously ill patient was connected to the device and ventilated.When the patient was turned into prone position as he was to undergo back surgery, difficulties with ventilation occurred.The bag collapsed and mechanical ventilation was no longer possible.Apnea- as well as leakage alarms were given by the device.It was further reported that the user refrained from turning the patient back again to check the connection between the device and the patient.The died in the intensive care unit after the operation.Based on the preliminary log analysis as well as testing of the device during on-site checking in follow-up to the event, no indications for a device malfunction were found.Even though it was reported that the patient was already ill, it cannot be excluded that a use error caused or contributed to the death of the patient.

Event Description

It was reported that a seriously ill patient was connected to the device and ventilated.When the patient was turned into prone position as he was to undergo back surgery, difficulties with ventilation occurred.The bag collapsed and mechanical ventilation was no longer possible.Apnea- as well as leakage alarms were given by the device.It was further reported that the user refrained from turning the patient back again to check the connection between the device and the patient.The died in the intensive care unit after the operation.Based on the preliminary log analysis as well as testing of the device during on-site checking in follow-up to the event, no indications for a device malfunction were found.Even though it was reported that the patient was already ill, it cannot be excluded that a use error caused or contributed to the death of the patient.

Manufacturer Narrative

Based on the logfile analysis, the case in question could be reconstructed and no indications for a device malfunction, but significant circuit leaks were found.During system test and leak test, internal and external leakages are detected.During use, based on leakage, fresh gas flow settings and set alarm limits, several audible and visible alarms would be issued as it was also in the particular case: the log analysis showed that just from the beginning of the case at 9:06am in volume control af mode, minute volume low, apnea and fresh gas low or leakage and emergency air inlet activated alarms were given accordingly to indicate the presence of a circuit leak.The user then repeatedly switched between manual and automatic ventilation, but the situation initially remained unstable.From around 9:20am, the ventilation in volume control af mode stabilized.Starting at 10:02am, significant circuit leaks occurred again, and the device issued alarms including apnea, minute volume low and fresh gas low or leakage.At 10:04am, the procedure was ended with the switching the device into standby.Dräger concludes that the reported symptom was caused by a significant leakage in the patient circuit leading to a loss of pressure, volume and fresh gas.Most likely, this leakage occurred during the reported repositioning of the patient.As initially reported ¿ and confirmed based on the log analysis ¿ the device issued several alarms to call the attention of the user.As also described in the ifu, the given alarms indicate a leakage or disconnection and the user shall check the patient condition, the tube or mask as well as the breathing circuit for tight connections and leakages.However, the user reportedly refrained from turning the patient back to check the connection.Therefore, it cannot be excluded that a use error contributed to the reported patient outcome.Based on the investigation results a device malfunction can be excluded as root cause.

• 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: 18854144
• MDR Text Key: 337067794
• Report Number: 9611500-2024-00096
• Device Sequence Number: 1
• Product Code: BSZ
• 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: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MK06000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2014
• 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): Death