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

Catalog Number 8606800

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Hypoventilation (1916); Hypoxia (1918)

Event Date 12/15/2018

Event Type  Injury  

Manufacturer Narrative

On-site evaluation in follow-up of the event revealed no nonconformities.In-depth analysis has just started, results will be provided in a follow-up report.

Event Description

It was reported to dräger that a patient became hypoxic during an anesthetic procedure.The user stated that the device did not alarm.The patient died.

Manufacturer Narrative

This follow-up report has been filed to correct the initially made statement in regard to patient outcome - the user has confirmed that the patient did not die but survived in critical condition.Further details are currently not known; investigation is ongoing.

Event Description

Please refer to initial mfr.Report.

Event Description

Please refer to initial mfr.Report.First it was reported that the patient died which was later revised to "survived in critical condition".Dräger has finally received the information that the patient expired at the end.

Manufacturer Narrative

Dräger was able to determine that three devices were used in a set-up for the particular procedure: a dräger anesthesia workstation of type fabius plus, a dräger scio gas analyzer module and a dräger multi-parameter patient monitor of type gamma xl.All these devices were tested and inspected by dräger in follow-up of the event and were found working according to specifications.The device log of the fabius plus does not contain any hint for the potential presence of a malfunction for the period in question; the scio has also no log entries pointing to an error condition.The log file of the patient monitor did not capture the particular sequence anymore since it was already overwritten with newer entries.Only very few details in regard to the procedure were disclosed to dräger.It was reported that the patient support was done in spontaneous ventilation mode i.E.The machine was not set to deliver breaths automatically.The monitoring of pressure and volume is however available in spontaneous ventilation mode as well.The fio2 monitoring is realized via the scio that provides gas readings to the gamma xl.It is not known to which limit the fio2 low alarm was adjusted at the gamma xl.In fact, the fio2 alarm can be disabled by the user at the gamma xl since the monitor is not only intended for use during anesthetic procedures but also for monitoring episodes where fio2 has no relevance.It is not known to dräger which circumstances caused the hypoxic condition of the patient; related questions were not answered by the user facility.The only conclusion that can be derived is that the monitoring facilities were available and functional during and after the event.It is under responsibility of the user to define the set of vital parameter that will be monitored for the individual patient and set the alarm limits adequately.

• Brand Name: FABIUS PLUS
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 8183798
• MDR Text Key: 130973896
• Report Number: 9611500-2018-00413
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: -
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 02/22/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2000
• Device Catalogue Number: 8606800
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/18/2018
• Initial Date FDA Received: 12/20/2018
• Supplement Dates Manufacturer Received: 01/21/2019; 02/20/2019
• Supplement Dates FDA Received: 01/22/2019; 02/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NA.; NA.; NA.
• Patient Outcome(s): Death; Life Threatening