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

Catalog Number 8608555

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/21/2019

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 ventilator failed during use and that the workstation posted a corresponding alarm.There was no injury reported.

Event Description

Please refer to the initial report.

Manufacturer Narrative

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

• 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: 8669657
• MDR Text Key: 147464089
• Report Number: 9611500-2019-00162
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 08/16/2019

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: 8608555
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/23/2019
• Initial Date FDA Received: 06/05/2019
• Supplement Dates Manufacturer Received: 08/15/2019
• Supplement Dates FDA Received: 08/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1