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

Catalog Number 8604700

Device Problems Intermittent Continuity (1121); Gas Output Problem (1266); Failure to Deliver (2338)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/13/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported there was a vent fail whist a patient was on the device.There was no patient injury reported.

Manufacturer Narrative

The responsible dräger service engineer could confirm the reported issue during on-site checking and could trace it back to the motor which was replaced consequently.Also the evaluation of the log file confirms an issue with the ventilator (motor) on the date of event.The log entries demonstrate that the supervisor function of the software forced a shutdown of automatic ventilation after detecting a stalled motor.This is a safety measure to prevent from mechanical damages to the ventilator unit.The user is alerted to the shutdown of automatic ventilation by a corresponding alarm; manual ventilation remains possible and, the other device functions like gas dosage and monitoring remain unaffected.Dräger finally concludes that the device behaved as specified upon the malfunction of a single component; no patient consequences have been reported.The repair exchange of the motor unit has fully solved the problem.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.

Event Description

It was reported there was a vent fail whist a patient was on the device.There was no patient injury reported.

• Brand Name: FABIUS GS PREMIUM
• Type of Device: ANESHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 11313042
• MDR Text Key: 231355224
• Report Number: 9611500-2021-00055
• 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: 03/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2021
• 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: 03/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1