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

Catalog Number 8607300

Device Problems Failure to Deliver (2338); Complete Loss of Power (4015); Unexpected Shutdown (4019)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/30/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation is still on-going.The results will be provided with a follow-up report.

Event Description

It was reported that the machine switched off during ventilation.No patient injury reported.

Manufacturer Narrative

The fabius service log file was analyzed.On the reported date of event an entry was found showing that the power supply has not delivered the required +28v resulting in an automatic switch to battery supply accompanied with the corresponding alarm.In the following the device posted additional alarms to indicate the remaining battery charge of 20% and 10% to the user until finally the device completely shut off due to depleted batteries.According to the log the user had enough time to react on the situation.Root cause for the missing +28v can be a disconnection of the power cord, a faulty power supply or a malfunction of the hospitals mains supply.Based on the log evaluation the exact root cause could not be determined.A review of the complete log file covering 1.5 years revealed that power supply problems occurred repeatedly in the past without initiating further measures as the issue remained.According to the log the last service was performed in november 2017.It is recommended to check the power supply on-site and to perform service as required.Finally it can be concluded that the device reacted as specified on the detected power supply failure by posting corresponding alarms, switching to battery supply and informing the user about the remaining battery charge.

Event Description

It was reported that the machine switched off during ventilation.No patient injury reported.

• 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: 10717419
• MDR Text Key: 212489747
• Report Number: 9611500-2020-00371
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 11/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• 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?: No
• Date Manufacturer Received: 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1