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

Catalog Number MK06000

Device Problems Gas Output Problem (1266); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bronchospasm (2598)

Event Date 03/30/2023

Event Type  Death  

Event Description

It was reported that the patient was inducted on the mask at 100%.But it was not noted on the screen that the concentration of dosed oxygen did not rise to the expected 100%, but remained low at 18%.With unsuccessful pre-oxygenation, bronchospasm was suspected, and it was decided to follow the "bronchospasm protocol." in doing so, the perseus continued to alarm and the etco2 increased.Eventually, the patient was resuscitated and transferred to (b)(6) mc where it died.

Manufacturer Narrative

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

Manufacturer Narrative

For the investigation the provided logfile was analysed.Based on the logfile analysis, the case in question could be reconstructed and no indications for a device malfunction were found.On the reported date of event the device successfully passed the system test.During the case in question the device issued from the beginning on several alarms, such as airway pressure high, airway pressure continuously high as well as apnea (no co2), while peak pressures of up to 40 and at times 65 mbar were measured with fluctuating peeps.Further a high etco2 was measured and alarmed, the inspiratory oxygen concentration intermittently decreased to <10 vol.%.According to the flight log no notable tidal volumes (vti/vte) were measured.The device issued adequate alarms, the alarms were confirmed and silenced by the user.After about one hour of operation a ventilation could be established.Adequate volumes were measured as well as etco2.The inspiratory oxygen concentration suddenly increased to >90 vol.% and also sevoflurane was detected (the vaporizer was set to 8.0 vol.% at 13:48).At 14:03 the unit was placed in standby.The perseus is equipped with an integrated pressure-, flow- and patient gas monitoring ensuring that deviations from set/expected parameters are obvious for the user and that alarms are given according to the alarm limits adjusted by the user.The analysis of the device logfile records has given no hints for a malfunction of the device.The situation presented by the logfile records suggests a pneumatic short circuit between the inspiratory and expiratory connectors of the breathing system and the legs of the y-piece (misconnection), however it was explained that a coaxial hose system was used.A faulty connection would not be possible with a flawless coaxial hose system.The hose system was not available for the investigation.Thus, finally, the exact root cause for the reported event could not be determined.However, based on the available information and the performed log analysis, no indications for a device malfunction were found.Dräger finally concludes that it could be excluded that the device has caused or contributed the reported patient death.

Event Description

It was reported that the patient was inducted on the mask at 100%.But it was not noted on the screen that the concentration of dosed oxygen did not rise to the expected 100%, but remained low at 18%.With unsuccessful pre-oxygenation, bronchospasm was suspected, and it was decided to follow the "bronchospasm protocol." in doing so, the perseus continued to alarm and the etco2 increased.Eventually, the patient was resuscitated and transferred to erasmus mc where he died.

• 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: 17037048
• MDR Text Key: 316281181
• Report Number: 9611500-2023-00206
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675253600
• UDI-Public: (01)04048675253600(11)211124(17)220222(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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/31/2023

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: 05/22/2023
• Initial Date FDA Received: 06/01/2023
• Supplement Dates Manufacturer Received: 07/28/2023
• Supplement Dates FDA Received: 07/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2021
• 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
• Patient Outcome(s): Death