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

Device Problem Electromagnetic Compatibility Problem (2927)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/13/2014

Event Type  malfunction  

Event Description

It was reported that a fabius mri anesthesia machine was moved in the proximity of an mri.The ventilator door of the fabius was opened by the magnetic forces and got stuck to the surface of the mri.There was no injury reported.

Manufacturer Narrative

The investigation is ongoing.We will provide results within a separate follow-up report.

• Brand Name: FABIUS MRI
• Type of Device: ANESTHESIA UNIT
• Manufacturer (Section D): DRAEGER MEDICAL GMBH; 53/55 moislinger allee; luebeck 2354 2; GM 23542
• Manufacturer Contact: frank clanzett ; moislinger allee 53-55; luebeck 23542 ; GM 23542 ; 518822868
• MDR Report Key: 4381398
• MDR Text Key: 18730675
• Report Number: 9611500-2014-00060
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K072884
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/17/2014

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
• Initial Date Manufacturer Received: 11/17/2014
• Initial Date FDA Received: 12/17/2014
• Date Device Manufactured: 03/01/2009
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1