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

Catalog Number 8604700

Device Problems Gas Output Problem (1266); Failure to Deliver (2338); Electrical Overstress (2924)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/12/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the fabius was being used as a long term ventilator on a covid 19 patient and that there was a power supply failure.According to the log records prior the power failure entries were found being in context with a ventilator failure.No injury reported.

Manufacturer Narrative

The investigation was performed based on the device log file and the returned motor.Not on the reported date of event but one day before suspicious log entries were found pointing to a motor shut-down due to an over-current condition.In this case the device shuts down automatic ventilation and alerts the user to this condition by means of a corresponding alarm.Manual ventilation and the monitoring functions remain available.The motor was replaced on-site and was provided for investigation.According to the serial number the motor was manufactured in 2003, 4 years before the involved fabius was manufactured.It can be assumed that the motor was assembled to the fabius after manufacturing in 2007.The received motor was found to be non-functional, rotation could not be started.The fabius motor assembly has brushes, ball bearing, commutator disk and a spindle which are affected from aging caused by wearing.As the device is 13 years old, a possible wear-and-tear related malfunction after such a long time of use is conceivable.Further analysis of the log revealed that after the over-current event records were found indicating that the battery ran empty.Verifying that the battery is fully charged is part of the pre-use check as described in the instruction for use and must be carried out before each patient use.With fully charged batteries the operation can be maintained at least for 45 minutes.In case of a power supply failure as initially reported the operation is continued using battery supply.This is optically and acoustically alarmed by the device and is additionally indicated to the user by the switched-off mains power led located on the user interface.If the battery is running low additional alarms are generated at a battery charge state of 20% and 10%.A discharged battery will cause a deactivation of the automatic ventilation and is accompanied by an optical and acoustical "vent failure" alarm.In case of a total loss of the electrical power the backup beeper will generate an acoustical alarm tone.The procedure can be continued using manual ventilation but without integrated monitoring.The power supply reportedly was replaced after the event but was not made available for investigation.Therefore the root cause for the power supply failure could not be determined.The number of similar cases (separately assessed for motor and power supply) are within the expected range of the respective risk assessment and thus accepted.Generally it has to be amended that using anesthesia machines for long term ventilation is not included in the ¿intended use¿ as stated in the instructions for use and therefore is an ¿off label¿ use.

Event Description

Please refer to the initial-report.

• Brand Name: FABIUS GS
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 10068672
• MDR Text Key: 191576367
• Report Number: 9611500-2020-00165
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K011404
• 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: 06/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8604700
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/20/2020
• Initial Date FDA Received: 05/19/2020
• Supplement Dates Manufacturer Received: 06/19/2020
• Supplement Dates FDA Received: 06/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1