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

Catalog Number 8608555

Device Problem Ventilation Problem in Device Environment (3027)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/06/2018

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 the device posted a ventilator failure during use and stopped automatic ventilation.There was no injury reported.

Event Description

Please refer to the initial-report.

Manufacturer Narrative

The reported ventilator failure could be comprehended by means of the device log file.On the date of the reported event two entries "motor stalled" and "motor slow" were found indicating deviations in the motor's rotation speed.As a safety function the ventilator was stopped accompanied by a corresponding "vent fail" alarm as specified for this situation.Manual ventilation is still possible and the patient status can be derived from the readings of the mandatory patient gas monitoring.The replaced motor of type parvex was received for investigation.The electrical characteristics of the motor (e.G.Rotation starting voltage) were found to be within specification.Also no failure of the incremental encoder (determining the motor position) was identified.The visual inspection of the collector disc has not shown any burn marks explaining a possible contact problem but has shown marks from the carbon brushes which were not even.Maybe this first indication of an emerging problem has caused the reported failure.Finally the replacement of the motor and the incremental encoder has solved the issue and the device was returned to use without further problems reported.The number of similar cases, related to the same root cause (parvex motor), is within the expected range of the respective risk assessment and thus accepted.

• Brand Name: FABIUS PLUS XL
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 7850537
• MDR Text Key: 119655558
• Report Number: 9611500-2018-00287
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: -
• 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: 10/05/2018

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: 8608555
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/07/2018
• Initial Date FDA Received: 09/06/2018
• Supplement Dates Manufacturer Received: 10/02/2018
• Supplement Dates FDA Received: 10/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1