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); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 05/25/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that there was a ventilator failure during use.There was no injury reported.

Manufacturer Narrative

For the investigation the logfile and the results from the tests done on site were analyzed.The described problem could be retraced.It was found that the device forced a shut down due to high current consumption of the ventilator motor.Root cause was most likely a faulty light barrier cable.The light barrier on the ventilator shall signalize when the piston reaches its lower limit during active ventilation to ensure that further movement into downward direction is stopped.In case of a faulty light barrier cable the piston may move further downward and gets stuck in end position.The motor current increases significantly during the attempt to drive the piston up again which triggers the safety shutdown then.In this case the device will generate an audible alarm and, the alarm message "ventilator fail" will be displayed.The user can switch to manual ventilation as described in the instructions for use.Monitoring is still functional.The service engineer replaced the light barrier cable on-site.The device was tested according to manufacturer's specification and was released into use.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.

Event Description

It was reported that there was a ventilator failure during use.There was no injury reported.

• Brand Name: FABIUS GS
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck ; GM
• MDR Report Key: 11997829
• MDR Text Key: 261694224
• Report Number: 9611500-2021-00253
• 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: 07/28/2021

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: 06/01/2021
• Initial Date FDA Received: 06/15/2021
• Supplement Dates Manufacturer Received: 07/23/2021
• Supplement Dates FDA Received: 07/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1