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

Catalog Number 8608555

Device Problems Use of Device Problem (1670); Failure to Deliver (2338)

Patient Problem Coma (2417)

Event Date 06/15/2023

Event Type  Injury  

Event Description

It was reported that during surgery the fabius plus screen turned off.The patient reportedly did not wake up after anesthetic induction and is in coma now.Based on the initial log analysis no entries were found for the time in question that could be associoated with the event.

Manufacturer Narrative

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

Event Description

It was reported that during surgery the fabius plus screen turned off.The patient reportedly did not wake up after anesthetic induction and is in coma now.Based on the initial log analysis no entries were found for the time in question that could be associated with the event.

Manufacturer Narrative

The investigation of the case in question was performed based on the provided information and the fabius plus xl log file.For the reported time in question no entries were registered in the log so that the reported event - device and monitor turned off - could neither be confirmed nor comprehended.In general, a shutdown of the device is accompanied by an alarm to inform the user about the situation.We were informed that no alarm was posted in connection with the reported (and not confirmed) shutdown.If automatic ventilation is no longer possible the procedure can be continued using manual ventilation as described in the instructions for use (ifu).Reportedly no pre-use check was performed before start of the procedure in question.According to the ifu a checkout must be performed daily before use of the device to ensure that the medical device is ready for operation.The fabius plus xl is equipped with an integrated volume and pressure monitoring.If alarm limits set by the user are reached a corresponding alarm is posted.Finally, no indication for a device malfunction could be identified.The reported shutdown could not be confirmed and there were no indications for a ventilator failure found.Thus, dräger concludes that a contribution of the device in question to the reported patient outcome can be excluded.Even in switched-off state, as also described in the ifu, spontaneous breathing as well as manual ventilation including all pneumatic functions, e.G.Apl valve, pressure gauge for the airway pressure, s-orc and flow control valves for o2, air and n2o are available.

• Brand Name: FABIUS PLUS XL
• 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: 17323963
• MDR Text Key: 319023718
• Report Number: 9611500-2023-00259
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675377610
• UDI-Public: (01)04048675377610(11)200206(17)200511(93)8608555-28
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 08/22/2023

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: 8608555
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/07/2023
• Initial Date FDA Received: 07/14/2023
• Supplement Dates Manufacturer Received: 08/04/2023
• Supplement Dates FDA Received: 08/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2020
• 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
• Treatment: NA.; NA.
• Patient Outcome(s): Hospitalization