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

Catalog Number 8604700

Device Problems Decrease in Pressure (1490); Inaccurate Delivery (2339); Gas/Air Leak (2946); No Pressure (2994)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/10/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported the unit was failing to ventilate in volume or pressure control mode.There was no patient injury reported.

Event Description

It was reported the unit was failing to ventilate in volume or pressure control mode.There was no patient injury reported.

Manufacturer Narrative

The dispatched fse could not duplicate the reported problems.The oxygen sensor and the flow sensor have been replaced but this is however not in context to the reported observations.The workstation was subject to several leak tests which were all passed, it was run in several ventilation modes and did not exhibit any deviations.The log files were evaluated by the manufacturer whereby it could be determined that there was a problem with the auxiliary air intake valve.From this fact can be concluded that a fresh gas deficit must have been present during the procedure in question.If the effects of this fresh gas deficit will create a negative pressure inside the ventilator during piston movement, the auxiliary air intake valve is being opened to take in room air to equalize the negative pressure and to ensure further operation of the ventilator.Obviously the air intake valve was sticking which led to temporary stop of ventilator operation; the device alarms for vent fail but continues operation autonomously as soon as the triggering condition deceases.Based on experience, a sticking of the valve occurs when the reprocessing recommendations of the manufacturer were not followed.Dräger finally concludes that the initial user description of "failure to ventilate" has rather to be interpreted as "insufficient ventilation".Most likely, a significant leak in the pneumatic circuit has led to the fresh gas deficit.The device is designed to post a corresponding alarm and to open the auxiliary air intake valve for compensation.This failed at one instance and led to a short-term interrupt of piston movement.The user may have observed the temporary displayed vent fail alarm and developed the perception that ventilation may have stopped.But indeed a stop triggered by such condition lasts only parts of a second, typically.

• 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: 10533664
• MDR Text Key: 206956483
• Report Number: 9611500-2020-00325
• 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: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2020
• 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
• Date Manufacturer Received: 12/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1