MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH MAGNETOM SKYRA; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number 10432915

Device Problem Use of Device Problem (1670)

Patient Problems Burn(s) (1757); Patient Problem/Medical Problem (2688); Lead(s), Burn(s) From (3161)

Event Date 08/26/2014

Event Type  Injury  

Manufacturer Narrative

The electrodes used are labeled mr conditional by the manufacturer; however, the use of the electrodes is not approved by siemens (unilect tm 4841p electrodes, unomedical ltd.(b)(4)).(b)(6).

Event Description

Siemens became aware of an adverse event involving a siemens magnetom skyra system through an article published in the journal of radiology and imaging.An unusual case of a third degree skin burn was reported using mri electrocardiographic leads.The electrodes are labeled mr conditional by the manufacturer, however, the electrodes are not a siemens approved product.The vendor of the electrodes was informed by the user when the incident occurred, however, siemens was not informed of the incident as no malfunction of the siemens system was observed.The patient was treated with aquagel and a foam bandage.

• Brand Name: MAGNETOM SKYRA
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; henkestrasse 127; erlangen, germany 91052 ; GM 91052
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; henkestrasse 127; erlangen, germany 91052 ; GM 91052
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 6104486461
• MDR Report Key: 8539386
• MDR Text Key: 142738740
• Report Number: 3002808157-2017-00879
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K141977
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 02/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10432915
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR
• Patient Weight: 90