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

Catalog Number 8607300

Device Problems Gas Output Problem (1266); Failure to Deliver (2338); Electrical Overstress (2924); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/15/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a ventilator failure occurred during use.There was no detail in the report which would reasonably suggest that patient consequences might have occurred.

Manufacturer Narrative

The dispatched service technician has examined the device in follow-up of the event.The error condition could be confirmed - the ventilator failure occurred because the supervisor function of the system detected a significantly increased motor current.A shut-down of automatic ventilation was forced which was accompanied by a corresponding alarm.The technician replaced the motor and the inner piston diaphragm.The unit passed all consecutive tests and was returned to use.There was no log file available anymore which would cover the period in question and the replaced parts were already discarded when the manufacturing site placed a request for being provided with these.Based on the description from the service report, a reasonable explanation would be that the inner piston diaphragm got wrinkled or has lost the intended position for unknown reason which then led to restrictions in piston movement and - consequently - in an increased current consumption of the ventilator motor.The system responded as designed by forcing a shutdown of automatic ventilation and by posting the appropriate alarm to alert the user.Manual ventilation with the built-in breathing bag remains possible.The device is subject to routine service inspections in regular intervals where several parts are preventively replaced.The particular diaphragm belongs to the 2-year maintenance kit; the field failure rate confirms that the replacement interval is appropriate.

Event Description

Please refer to the initial-report.

• Brand Name: FABIUS MRI
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 9144126
• MDR Text Key: 184157613
• Report Number: 9611500-2019-00308
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K072884
• 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: 11/14/2019

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: 8607300
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/16/2019
• Initial Date FDA Received: 10/02/2019
• Supplement Dates Manufacturer Received: 10/09/2019
• Supplement Dates FDA Received: 11/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1