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

Catalog Number 8607300

Device Problems Intermittent Continuity (1121); Gas Output Problem (1266); Failure to Deliver (2338)

Patient Problem Insufficient Information (4580)

Event Date 09/23/2021

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 unit restarted multiple times during use.There was no patient injury reported.

Event Description

It was reported that the unit restarted multiple times during use.There was no patient injury reported.

Manufacturer Narrative

Investigation was performed based on the device log file and the additionally provided information.A dräger technician was on-site and confirmed the reported restarts.A mechanically damaged 28v dc cable on the control board was identified to be root cause for the reported symptom.Reportedly, the cable was damaged by the biomed during replacement of the control box, which was performed before the event.A picture of the affected area was provided.Based on that, it could be confirmed that by this damage, the cable from power supply to the dc supply was affected leading to the reported symptom.Also based on the log analysis, this damaged dc cable as root cause could be strengthened.Even though the log records were overwritten and only started at 11:17am on the reported date of event, entries were found pointing to a failure pattern correlating with the identified cable issue.The power supply itself was working but did not provide enough energy to fully operate the fabius.In consequence, energy was taken simultaneously from the backup batteries as well until the backup batteries were depleted and the fabius finally shut down.After the shutdown, the fabius mri was connected to mains power in switch-on state.The power supply provided sufficient energy to start the device but when more energy was required, it again shut down and restarted.This sequence has been repeated several times and could also be comprehended based on the log analysis as a high number of "system power on"-messages was found.As only the "switching on" sequence is logged, the device had to be switched off in between.This fits to the reported symptom of multiple restarts, so that the fabius device was switching on and off all the time.In general, a power loss is accompanied by a corresponding alarm buzzer whereby the fabius mri additionally indicates this state by a warning light.In case the capacity of the backup battery falls below 20% respectively 10%, corresponding alarms are posted.Dräger finally concludes that the damaged dc power supply cable was the root cause for the reported symptom.It can be concluded that the replacement of the control box prior the case in question by the biomed has damaged the cable and finally resulted in the reported symptoms.This case can be considered as single event as no similar case has been reported before.

Event Description

It was reported that the unit restarted multiple times during use.There was no patient injury reported.

Manufacturer Narrative

Due to a technical issue with our internal emdr system we submitted for the form fda 3500a an incorrect value for the field h3.- not returned to manufacturer.

• Brand Name: FABIUS MRI
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck ; GM
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 12582050
• MDR Text Key: 276388816
• Report Number: 9611500-2021-00414
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675041498
• UDI-Public: (01)04048675041498(11)180129(17)180708(93)8607300-45
• Combination Product (y/n): N
• PMA/PMN Number: K072884
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 06/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/28/2021
• Initial Date FDA Received: 10/06/2021
• Supplement Dates Manufacturer Received: 10/12/2021; 10/12/2021
• Supplement Dates FDA Received: 12/01/2021; 06/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2021
• 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