MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA FABIUS GS; ANESTHESIA UNITS

Catalog Number 8604700

Device Problem Use of Device Problem (1670)

Patient Problem Emotional Changes (1831)

Event Date 04/19/2022

Event Type  Injury  

Event Description

It was reported that the machine failed its self check on the morning of surgery.This was not identified at the time by staff and the patient suffered a hypoxic episode in theatre.Equipment removed and sent to eme for investigation who were unable to detect fault.Draeger notified directly (customer inventory number 137694).Reported to mhra to highlight risk of interchangeability of circuits and visibility of failed self-test alert on draeger anaesthetic machines on (b)(6) it was further reported that following the hypoxic episode and abandonment of the surgery, the patient has gone on to develop post-traumatic symptoms with panic, fear of sleeping, flashbacks and anxiety.She remains under the care of our health psychological team.

Manufacturer Narrative

Dräger received a user facility report about a case dated back on april 2022, no logfiles were available for the investigation.The analysis includes the provided photos from september 2023, which recreate the displayed message in 2022.The fabius gs was tested after the event without any failure found.Reportedly the fabius gs failed it¿s self check prior to the case in question and posted the message ¿leak compliance test failed ¿ leak >350mls¿.Nevertheless the users decided to put the device into operation and started a case.It was further reported on (b)(6), 2023, that the patient suffered from a hypoxic episode, the surgery was stopped and the patient has subsequently developed post-traumatic symptoms.Due to the missing electronic logfile a detailed reconstruction of the case was not possible.The device was tested after the event without any failures found.None of the available information indicates that a failure of the fabius gs has led to the patient harm.The fabius detected a leak during the regular self-test routine and posted a corresponding message to inform the user.It was the user¿s decision to put the device into operation despite the failed test.Furthermore, it is responsibility of the user to provide monitoring of o2, co2 and agent as described in the fabius gs instructions for use.Such monitoring ensures that restrictions of ventilation are readily apparent to the user.Corresponding alarms would be generated depending on the thresholds adjusted by the user.

• Brand Name: FABIUS GS
• 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: 17875738
• MDR Text Key: 324975726
• Report Number: 9611500-2023-00334
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K011404
• 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: 09/22/2023

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: 8604700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/21/2023
• Initial Date FDA Received: 10/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2005
• 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