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

Model Number 8607300

Device Problems Use of Device Problem (1670); Failure to Calibrate (2440); No Apparent Adverse Event (3189)

Patient Problem Hypoxia (1918)

Event Date 11/04/2022

Event Type  Injury  

Event Description

It was reported that a patient had an acute hypoxemia.Resuscitation maneuvers were performed.In consequence a vegetative state was reported.

Manufacturer Narrative

The investigation is still ongoing, the results will be provided in a follow-up report.

Manufacturer Narrative

The device log file was analyzed for the reported date of event (b)(6) 2022.The device was switched on at 09:11am.About an hour later, at 10:24 and 10:37, negative airway pressures below -10mbar had been logged.The fabius anesthesia workstation is equipped with a so-called auxiliary common gas outlet (acgo) to enable induction of the patient with a non-rebreathing system.The fresh gas delivered by the gas mixer has to be routed via a dedicated switch to either the compact breathing system (cosy) for automatic ventilation or to the acgo.According to the information received the patient was connected to the cosy, the fabius was in controlled ventilation, but the acgo switch was in the other position so that the fresh gas was directed to the external fresh gas outlet.In this case the volume inside the breathing circuit and patient lung will circle inside the cosy during ventilation without delivery of fresh gas to the patient.In the following due to uptakes from the patient and co2 absorbent, a vacuum inside the ventilator occurred which is recognizable by the deflation of the breathing bag.In this situation the negative pressure safety relief valve will open at ¿7.5 to ¿9 mbar to take in ambient air.Thereby, the fresh gas will be diluted so that the concentration of gases will be decreased.The negative pressure safety relief is a protection against negative pressure inside the breathing circuit, it is not a protection against hypoxic gas concentrations.Further, it can be assumed that the temporary negative airway pressures registered in the log were also a result of the vacuum which has been created.In case the airway pressure falls below -10mbar automatic ventilation is temporarily stopped which is accompanied by a corresponding alarm.If the pressure is back in the permitted range, automatic ventilation is resumed.It can be assumed that this condition was only present for a few seconds, as the safety relief valve will open to rectify this negative pressure condition.The fabius is equipped with an fio2 sensor to measure the inspiratory concentration.If set alarm limits are reached a corresponding alarm e.G., ¿insp o2 low!!!¿ is posted.It was found during inspection on-site that the fabius was equipped with a non-functional o2 sensor from a different manufacturer.A non-functional o2 sensor is detected during calibration and the pre-use check which must be performed daily.Furthermore, it is obvious for the operator during use when no o2 value is being displayed based on the information provided no external monitoring had been used.The ifu contains related information.Warning - risk of patient injury every user has the obligation to assess independently which components are required corresponding to the specific prerequisites for the anesthesia workstation.In accordance with the general safety standards for anesthesia systems, additional monitoring of the concentrations of co2 and anesthetic agent is required when operating the device.To guarantee patient safety, however, the following components must always be used: ¿ o2 monitor ¿ pressure monitor ¿ volume monitor besides these instructions customers having fabius devices with a acgo switch in their fleet have received additional information about the usage of this switch.A supplement to the ifu and additional labels which needed to be installed onto the front panels of the fabius devices were provided.According to the documentation the customer confirmed to have received the information but finally, the labeling of the machine had not been updated by the customer.It can be concluded that a chain of use errors was root cause of the reported event and patient outcome.The acgo switch was set to a wrong position, no required patient gas monitoring was used and, receipt of information from the manufacturer to prevent this situation was confirmed but finally ignored and not conducted.No hints for the potential presence of a device malfunction were found.

Event Description

It was reported that a patient had an acute hypoxemia.Resuscitation maneuvers were performed.In consequence a vegetative state was reported.

• Brand Name: FABIUS MRI
• 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
• MDR Report Key: 16172959
• MDR Text Key: 307468590
• Report Number: 9611500-2023-00012
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675041498
• UDI-Public: (01)04048675041498(11)170104(17)170521(93)8607300-42
• Combination Product (y/n): N
• PMA/PMN Number: K072884
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/17/2023

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 Model Number: 8607300
• Device Catalogue Number: 8607300
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/06/2023
• Initial Date FDA Received: 01/16/2023
• Supplement Dates Manufacturer Received: 02/15/2023
• Supplement Dates FDA Received: 02/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2016
• 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): Hospitalization; Life Threatening; Required Intervention