MAUDE Adverse Event Report: DRAEGER MEDICAL GMBH FABIUS MRI; ANESTHESIA UNITS

Device Problems Sticking (1597); Device Damaged by Another Device (2915); Electromagnetic Compatibility Problem (2927)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/19/2015

Event Type  malfunction  

Event Description

While being moved too close to the mri device the fabius mri was attracted by the magnetic field and got stuck on the surface to the mri device.The mri had to be shut down in order to remove the fabius mri which got damaged due to the collision.There was no injury reported.

Manufacturer Narrative

The investigation was started but is not yet concluded.The investigation result will be reported in the final-report.

Manufacturer Narrative

The description of the event and the instructions for use provided a basis for the investigation.The device was not investigated.The reported event could not be confirmed on the basis of the information available.Within the area with a field strength of more than 40mt the device is subject to significant power of attraction which causes the device to be strongly accelerated.The warnings within the instructions for use refer to the "use" of the device in this area while it is not explicitly emphasized that the transport of the device in the switched off state in this area is meant as well.Patients and operators may be injured.One similar incident has been reported since the fabius mri was launched.In the course of the capa 49769 the customers will be informed via a supplement to the instructions for use about the danger of transporting the switched off device into or through a 40mt area.The investigator recommends to mark the 40mt field strength boundary on the floor of the room where the mri is installed.

• Brand Name: FABIUS MRI
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRAEGER MEDICAL GMBH; 53/55 moislinger allee; luebeck ; GM
• Manufacturer Contact: frank clanzett ; 53/55 moislinger allee; luebeck 23542 ; GM 23542 ; 518822868
• MDR Report Key: 4922500
• MDR Text Key: 20126842
• Report Number: 9611500-2015-00114
• Device Sequence Number: 1
• Product Code: CBK
• 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,company representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 06/25/2015

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/27/2015
• Initial Date FDA Received: 06/25/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2013
• 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