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

Device Problem Device Alarm System (1012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/26/2019

Event Type  malfunction  

Manufacturer Narrative

The dispatched service engineer could narrow down the root cause for the problem to a worn ventilator motor and replaced it.The device passed all tests after the repair exchange and was returned to use without further problems reported.The manufacturer has evaluated the log file and found entries which are in relation to the reported ventilator failure.As also initially reported two different error codes were found in the log; first one is indicating speed deviations (motor slow) and the second one a stalling of the motor, finally.In the end dräger concludes that the device responded as designed upon the malfunction of a wear-and-tear component; it has shut down automatic ventilation when the error occurred to prevent from damages to the ventilator unit and posted a corresponding alarm.Manual ventilation remains possible in this state.Reportedly, no patient consequences have occurred.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 and the device generated alarms.There was a message "motor slow" and the motor stalled.There was no patient injury reported.

• Brand Name: FABIUS PLUS
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• Manufacturer Contact: sonja hillmer ; moislinger allee 53-55; lübeck 23542 ; GM 23542 ; 4518822868
• MDR Report Key: 9144427
• MDR Text Key: 185102791
• Report Number: 9611500-2019-00301
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K011404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/06/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/30/2015
• 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