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

Catalog Number 8607000

Device Problem Unexpected Shutdown (4019)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/26/2020

Event Type  malfunction  

Manufacturer Narrative

The event dates back to (b)(6) 2020 and, the user did not involve dräger that time.Due to the long delay in the information chain it was not possible to obtain further details about the event.Similar events have been reported in isolated numbers in the past.These were related to situations where the user started therapy with a depleted internal battery and ran into an unexpected outage of mains supply.This is beyond the control mechanisms a manufacturer can establish and does not represent a single-fault condition.It is seen likely that this explanation applies here as well, a technical reason can however not be fully excluded due to lack of information.Thus, this report is filed in abundance of caution.

Event Description

It was reported that the device suddenly shut down during use but resumed ventilation 2 minutes later.Reportedly, the user had bridged patient support in manual ventilation in between; no patient consequences have occurred.

• Brand Name: FABIUS GS PREMIUM
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 10769367
• MDR Text Key: 223206496
• Report Number: 9611500-2020-00390
• 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: user facility
• Type of Report: Initial
• Report Date: 11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8607000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/29/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1