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

Catalog Number 8607000

Device Problems Sticking (1597); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/17/2016

Event Type  malfunction  

Manufacturer Narrative

The investigation was started but is not yet concluded.The investigation result will be reported in a follow up-report.

Event Description

It was reported that the expiratory valve disk on the cosy was intermittently sticking during a case and the machine alarmed for 'vent fail'.The user reportedly swapped out the cosy and completed the case with no patient injury reported.

Manufacturer Narrative

It was initially reported that the expiratory valve disc on the cosy was intermittently sticking leading to a ventilator failure.Such symptom could also have been caused by a sticking peep/pmax valve.It is in series with the expiratory valve.If the active pneumatic peep/pmax valve is stuck closed the passive expiratory valve will also not open.As only the valve disc of the expiratory valve is visible for the user a peep/pmax valve stuck closed could easily have been mistaken for an expiratory valve stuck closed.This assumption could be confirmed on the basis of the log analysis as described subsequently.If the peep/pmax valve does not close completely an expiratory flow during the inspiration is existent leading to a corresponding log entry if the flow is at least 15ml.Such entries were found in the log.If the peep/pmax valve does not open completely or not as fast as required breathing gas will remain in the lung causing an increased pressure during the next inspiration phase.If the pressure is 10mbar above pmax for 10ms a corresponding log entry is entered to the log which was found several times.In this case the piston motor and vacuum pump are switched off for 200ms and are restarted afterwards.If this state remains or returns within the next 2 seconds a ¿safety shutdown¿ is proceeded and is entered to the log.The ventilator is shut down for safety reason to protect the patient from overpressure and a ¿vent fail¿ alarm is generated.According to the log this event was also recorded.In case of a ventilator failure the case can be continued using manual ventilation as it was done in the reported case.The safety system has reacted and alarmed as specified.It is essential for this kind of failure that the user performs the pre-use checkout and follows the cleaning procedure as described in the ifu.On the basis of the log analysis the root cause for the reported ventilator failure could be attributed to a sticking peep/pmax valve.The valve was cleaned on site.Afterwards the system was tested successfully and was returned to use.

Event Description

Please see initial-report.

• Brand Name: FABIUS GS PREMIUM
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• Manufacturer Contact: sonja hillmer ; moislinger allee 53-55; lübeck 23542 ; GM 23542 ; 4518822868
• MDR Report Key: 6176503
• MDR Text Key: 62848699
• Report Number: 9611500-2016-00381
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 01/20/2017

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: 8607000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2016
• Initial Date FDA Received: 12/15/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/20/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/30/2005
• 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