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

Catalog Number 8607300

Device Problems No Display/Image (1183); Gas Output Problem (1266); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/16/2023

Event Type  Injury  

Manufacturer Narrative

The investigation has just started; results will be provided in a follow-up report.On-going.

Event Description

It was reported that the patient was ventilated for about 30-40 minutes in the mri when the display of the fabius mri failed.Further ventilation was no longer possible with the fabius, so the mri examination was stopped.The patient could be adequately ventilated with the ambu bag.No patient injury reported.

Manufacturer Narrative

The device log file was analyzed.At the time of the reported event a "motor stalled" entry was found indicating an issue with the ventilator motor.The device monitors the speed, rotation angle and other performance parameter of the motor continuously.Any speed fluctuations or other deviations may result in a divergence between expected piston position and the real hub that has been performed.The piston hub defines the applied tidal volume and thus, to prevent from potentially hazardous output and/or from damages to the ventilator unit, the system is designed to shut down automatic ventilation and to alert the user to this condition by means of a corresponding alarm.In case automatic ventilation is shut-down manual ventilation and monitoring functions remain available.The motor was replaced on-site and was provided for investigation.Different test scenarios were performed without provoking an error so that finally the root cause for the stalled motor could not be determined.Besides the issue that the patient could not be ventilated, a display failure was reported.Therefore, the control unit also comprising the display with backlight inverter was replaced and was analyzed at manufacturer site.Tests revealed a faulty backlight converter as root cause for the reported dark display.A non-functional display is obvious for the user.Normally, in case of a display failure automatic ventilation is continued.As for the current case automatic ventilation was stopped due to a stalled motor manual ventilation can be used to continue the procedure.The number of similar cases, related to the same root cause (backlight converter), is within the expected range of the respective risk assessment and thus accepted.As the root cause for the stalled motor could not be determined a corresponding assessment is not possible.Although both events (motor stalled and dark display) happened around the same time there were no hints found that the two events are related to each other.

Event Description

It was reported that the patient was ventilated for about 30-40 minutes in the mri when the display of the fabius mri failed.Further ventilation was no longer possible with the fabius, so the mri examination was stopped.The patient could be adequately ventilated with the ambu bag.No patient injury 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
• Manufacturer Contact: moislinger allee 53-55; lübeck 23542 ; 4518822868
• MDR Report Key: 16250168
• MDR Text Key: 308231301
• Report Number: 9611500-2023-00028
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K072884
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/27/2023

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8607300
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2023
• Initial Date FDA Received: 01/26/2023
• Supplement Dates Manufacturer Received: 02/23/2023
• Supplement Dates FDA Received: 03/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2011
• 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): Required Intervention