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

Catalog Number 8606000

Device Problem Defective Device (2588)

Patient Problems Cyanosis (1798); Hypoxia (1918)

Event Date 05/29/2019

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 the fabius device had a failure during surgery.The patient became hypoxic and cyanotic, heart rate decreased from 80/min to 40/min, blood pressure and spo2 could not be measured.After reported rescue, the patient¿s vital signs were stable and the operation could be continued.Reportedly, further treatment was necessary after the patient was in the icu.

Event Description

Please refer to the initial-report.

Manufacturer Narrative

It was further reported that the device failure was a ventilator failure during automatic ventilation mode, the device was not ventilating and thus, reportedly, leading to patient¿s hypoxia.In general, the fabius is equipped with an integrated pressure-, volume- and optional o2-monitoring.For the particular case, it was confirmed that the fio2 measurement of the fabius was used.As described in the instructions for use, an external monitoring unit according to iso 80601-2-55 must be used to perform the required monitoring of o2, co2 and anesthetic gas.Then, visible and audible alarms would be generated depending on the limits adjusted by the user.In case the fabius fio2-monitoring (inspiratory oxygen concentration) is in use, as it was in this case, a high priority ¿insp o2 low!!!¿ alarm will be given acoustically and optically if the measured fio2 concentration is out of the adjusted alarm limits.It was reported for the particular case that the device generated alarms.Based on the logfile analysis, two entries were found.Both indicate that an overpressure condition occurred upon which the device reacted as designed with a ventilator shutdown.The first code was logged because the measured airway pressure was more than 10mbar above the pmax limit adjusted by the user for more than 20ms.In this case, the ventilator motor performs a zeroing maneuver for the piston position which is not visible for the user and does not lead to an impact on the ventilation performance.The second error code indicates that the overpressure condition was indeed present for more than 400ms.In consequence, the supervisor function of the software forced a shutdown of automatic ventilation to prevent an overpressure condition for the patient.This is accompanied by a corresponding ¿ventilator fail !!!¿ alarm; manual ventilation as well as monitoring functions remain available.The imaginable root causes are manifold and not necessarily related to technical issues patient coughing, patient movement, accidental occlusion of the breathing hose etc.May cause the aforementioned overpressure situation as well.However, a reliable conclusion in regard to the exact root cause is not possible based on the available information.Dräger finally concludes that the workstation responded as designed upon a deviation of unknown origin to protect the patient from overpressure.No health consequences have been reported.

• Brand Name: FABIUS TIRO
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 8690144
• MDR Text Key: 147711751
• Report Number: 9611500-2019-00171
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675041474
• UDI-Public: (01)04048675041474(11)161208(17)170501(93)8606000-83
• Combination Product (y/n): N
• PMA/PMN Number: K042419
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 08/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2019
• 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: 8606000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NA.; NA.
• Patient Outcome(s): Life Threatening