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

Catalog Number MK06000

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Unspecified Respiratory Problem (4464); Insufficient Information (4580)

Event Date 01/17/2023

Event Type  Injury  

Manufacturer Narrative

The investigation has just started; results will be provided in a follow-up report.

Event Description

It was reported that during operation, there was a pressure rise up.Reportedly the patient suffered a barotrauma.

Manufacturer Narrative

Based on the logfile analysis, the case in question could be reconstructed and the reported high airway pressure could be confirmed.However, no indications for a technical malfunction were found.The case in question was started at 1:28pm, using man/spont and continued in volume control from 1:41pm.During the following ventilation episode the device alarmed repeatedly for apnea, minute volume low and airway pressure (continuously) high while peak pressures of up to 48 hpa with a peep of up to 30 hpa were measured, indicating the inability to fully release pressure during the expiration.It could be reconstructed that the user switched between the modes but without any notable improvement of the situation.At 1:55pm, the unit was placed in standby.Later the day a system test was performed and passed.Finally, based on the evaluation of the electronic device logfile, no indications for a technical malfunction were found.It could be concluded that the observed and alarmed increase of airway pressure most likely was caused by an obstruction in the expiratory path of the breathing system.A reasonable explanation would be that one of the valves which control the ventilation cycles was sporadically sticking in closed position for unknown reasons.Based on former complaint investigations, a reprocessing issue could have led to the sporadic sticking.In particular, the presence of humidity increases the adhesion of the valve discs; insufficient dying at the end of reprocessing may have left humidity in the breathing system which could then later evaporate and was thus not present anymore during the next system test.Dräger finally concludes that there was no technical device failure contributing to the reported barotrauma.This conclusion is reinforced by the fact that the performed system test after the case in question was passed without any issues found and the aspect that the device was continued to be used after the case in question without further issues.During on-site checking in follow-up to the event, no indications for a device malfunction were found either.An obstruction will be detected during system test prior use.During use, the integrated airway pressure monitoring allows a permanent control of pressure.In the case of high and/or continuous pressure situations appropriate alarms are given.

Event Description

It was reported that during operation, there was a pressure rise up.Reportedly the patient suffered a barotrauma.

• 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: 16434600
• MDR Text Key: 310132579
• Report Number: 9611500-2023-00071
• 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: 04/20/2023

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?: No
• 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: 02/17/2023
• Initial Date FDA Received: 02/24/2023
• Supplement Dates Manufacturer Received: 04/03/2023
• Supplement Dates FDA Received: 04/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2015
• 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