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

Catalog Number 8604700

Device Problems Device Alarm System (1012); Gas Output Problem (1266); Failure to Deliver (2338)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/23/2019

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 there was an apnea pressure and a ventilator failure alarm during a case.There was no injury reported.

Manufacturer Narrative

The particular device is 14 years old.It was checked on-site by a dräger technician who wasn't able to duplicate the error.The device was tested in detail but it exhibited no deviations during these tests.It was returned to use with no further problems reported since then.The log file was evaluated by the manufacturer.The reported issue can be confirmed in general - there are entries for the period in question which are pointing to occurrence of motor speed deviations.The motor is equipped with a collector disc and carbon brushes - these parts are subject to wear and tear.It sounds reasonable after such a long time of use that the carbon brushes have reached wear and tear limit and sporadically loose the electric contact to the collector which results in speed fluctuations.The system is constantly monitoring the measured actual speed against the expected one and is designed to shut down automatic ventilation if the divergence exceeds a certain threshold.This behavior is intended to protect the ventilator unit from serious damages.The shut down is accompanied by a corresponding alarm, manual ventilation remains possible.It was recommended to the customer to let draeger check the motor and to replace it if considered necessary.The motor is designed for a lifetime of 10 years; the exhibition of wear and tear related malfunction after almost 15 years can be considered well-acceptable.

Event Description

Please refer to initial mfr.Report.

• 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: 9139517
• MDR Text Key: 183770159
• Report Number: 9611500-2019-00304
• 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: 11/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2000
• Device Catalogue Number: 8604700
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1