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

Catalog Number 8604700

Device Problems Use of Device Problem (1670); Failure to Deliver (2338)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/03/2020

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 about 3h30 into a case the device stopped ventilating the patient.There was no injury reported.

Event Description

It was reported that about 3h30 into a case the device stopped ventilating the patient.There was no injury reported.

Manufacturer Narrative

The local service organization has tested the device in follow-up of the event whereby it did not exhibit any malfunctions.The transmitted error codes that were found in the logs during on-site evaluation give no clear hint for the circumstances that have led to the user's observation.A case-specific evaluation is not possible and a reliable conclusion in regard to potential root cause can't be drawn.In case the fabius shuts down automatic ventilation the device will generate an audible alarm and a visible alarm message "ventilator fail" will be displayed.The user can switch to manual ventilation as described in the instructions for use; monitoring is still functional.

• Brand Name: FABIUS GS
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 10435757
• MDR Text Key: 203828457
• Report Number: 9611500-2020-00297
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8604700
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1