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

Catalog Number 8608555

Device Problems Gas Output Problem (1266); Incorrect Interpretation of Signal (1543); Failure to Deliver (2338); No Pressure (2994)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/30/2019

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 vent failed during surgery.There was no patient injury reported.

Manufacturer Narrative

The device log indicates that the sensor for monitoring the airway pressure had malfunctioned.If the airway pressure monitoring which is based on this sensor does not work, overpressure conditions could not be detected.Thus, if this error is occurring during use, the device shuts down automatic ventilation to protect the patient from potentially hazardous output.The user is being alerted to the ventilation shut down by means of a corresponding alarm.The daily as well as the pre-use check will detect the particular error condition if the malfunction does not come up during a running ventilation episode.There's only one similar complaint known within the last four years.Dräger finally concludes that the device responded as designed upon the malfunction of a single electronic component.

Event Description

Please refer to initial mfr.Report #9611500-2019-00371.

• 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: 9289380
• MDR Text Key: 180404312
• Report Number: 9611500-2019-00371
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675377610
• UDI-Public: (01)04048675377610(11)170623(93)8608555-23
• 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: 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8608555
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1