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

Catalog Number 8607300

Device Problem Inaccurate Delivery (2339)

Patient Problem No Information (3190)

Event Date 03/01/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported there was a negative pressure alarm and the vt was inaccurate during a case - the doctor had to stop the procedure.

Manufacturer Narrative

The dispatched fse was unable to download logs from the machine.After replacement of the main board the device passed all tests and could be returned to use.The main board was evaluated by the manufacturer.Visual inspection revealed several mechanical damages like broken ferrites and cable connectors.It is however seen likely that these damages were caused by e.G.Dropping the board to the floor after de-installation and that the actual condition has no relation to the reported event.The failure to retrieve logs can be confirmed, a memory error is the most likely root cause since all other functions work according to specifications.Dräger is not aware of any memory failures which occurred under the conditions of the intended use.There are individual complaints known where memory errors came up after the machine had been exposed to x-rays.For the particular case it could not be determined if this explanation applies here as well.The reported negative pressure alarm was most likely related to the procedure or to patient condition.For example, a fresh gas deficit in combination with spontaneous breathing efforts of the patient may cause such effect or the use of a bronchial suction system.Without the possibility to evaluate the log file is no reliable conclusion possible but there was no indication that a technical error condition may have caused this - the unit passed all functional tests.The additionally observed deviation in the delivered tidal volumes was related to an improper repair - a component with a wrong hardware revision state was used to correct another issue about one year ago.All issues of the machine have been corrected by the main board replacement.

Event Description

Please refer to initial mfr.Report.

• 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: 8482051
• MDR Text Key: 141089904
• Report Number: 9611500-2019-00104
• 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: 05/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2019
• 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: 8607300
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1