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

Catalog Number 8604700

Device Problem Tidal Volume Fluctuations (1634)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/17/2018

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 ventilator was not working properly - the tidal volume was unstable.Log analysis revealed that a ventilator failure occurred.There was no injury to the patient.

Manufacturer Narrative

The investigation was carried out based on the available information and the analysis of the service log entries from the transmitted photo.The reported symptom could be understood.By analyzing the photo, two entries of m007 and m006 in context to the described symptom (ventilator was not working properly) were found.The m006 entry is logged when the airway pressure (paw) has gone very negative (less than -10mbar) during a ventilator operating mode.The device alarms for "pressure negative" if the measured paw is less than ¿6.5 mbar.The m007 event is logged when the pressure inside the ventilator cylinder drops below -15 mbar.As a precaution, the piston pressure controller stops the ventilator temporarily and the device alarms accordingly with ¿ventilator fail¿.In case the device shuts down automatic ventilation, the device will generate according alarms, as it was in this specific case.Monitoring and manual ventilation remains functional.It was reported as additional information that during use, a suction was used.This is, besides e.G.Patient activity, a possible root cause for this m006 entry.A possible root cause for the m007 entry is an issue with the valve that is located on the top of the ventilator and that can dose ambient air into the cylinder in case of insufficient fresh gas flow.It is possible that this valve sticks if the cleaning recommendations of the instructions for use are not followed.It was reported additionally that the ventilator cover of the involved device never has been cleaned.Further it was reported that the tidal volume was unstable vt, so 550ml were adjusted and 1100 measured.This symptom points to a sticking peep-valve placed inside the cosy.A strong sticking peep-valve can cause that two sequent-breathing-swings can add on each other so that the threshold of the peak pressure will detect just one breathing swing, instead of two.The fabius device is equipped with integrated volume-monitoring.During use, if the delivered minute volume is less than set, alarms will be generated depending on the alarm limits adjusted by the user.The number of similar cases is within the expected range of the respective risk assessment and thus accepted.However, in the framework of continuous product improvement a design change of the peep valve placed inside the cosy has been started to prevent sticking which can cause the described issue.Dräger finally concludes that the device responded as specified upon the symptom; no patient consequences have reportedly occurred.

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: 7808185
• MDR Text Key: 118239005
• Report Number: 9611500-2018-00265
• 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: 09/20/2018

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 Expiration Date: 01/01/2000
• Device Catalogue Number: 8604700
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/25/2018
• Initial Date FDA Received: 08/23/2018
• Supplement Dates Manufacturer Received: 09/20/2018
• Supplement Dates FDA Received: 09/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1