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

Catalog Number 8607300

Device Problems Electrical /Electronic Property Problem (1198); Loss of Threshold (1633); Device Sensing Problem (2917); No Pressure (2994)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/03/2019

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 automatic ventilation failed during use.The device generated visible and audible alarms.There was no injury reported.

Manufacturer Narrative

The electronic log file was available for the investigation.Based on the information recorded in it, the reported failure of the automatic ventilation could be confirmed - but for october 2, 2019 and not for october 3, 2019, as originally reported.At 12:46 the fabius rdetected that the motor that drives the vntilator piston was not moving as expected.The entries v040 motor slow and v041 motor stalled were saved.In this case, the fabius mri issues an optical and acoustic ventilator failure alarm.The detected deviation in motor speed can have a variety of causes.In addition to faulty position detection, these are also a fault in the motor itself or a stiff piston mechanism.However, these could be excluded, sinde they would have resulted in specific entries in the log that were not found in the specific case.In the temporal context, however, an error of the temperature sensor, which monitors the charging circuit for the internal batteries, was logged.The saved ps07 temp sensor failure indicates that the sensor delivers unrealistic values.It was concluded that the fault had an impact on the charging of the battery and thus indirectly led to a drop in the motor voltage.The error of this temperature sensor is an isolated case.The replacement of the circuit board on which the temperature sensor is installed was recommended.

Event Description

Please refer to initial mfr.Report #9611500-2019-00384.

• Brand Name: FABIUS MRI
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 9314423
• MDR Text Key: 186760330
• Report Number: 9611500-2019-00384
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K072884
• 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: 02/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8607300
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1