MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH- MR MAGNETOM SYMPHONY SYNGO MR; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number 7104594

Device Problem Use of Device Problem (1670)

Patient Problems Bone Fracture(s) (1870); Head Injury (1879); Patient Problem/Medical Problem (2688)

Event Date 02/06/2020

Event Type  Injury  

Manufacturer Narrative

A siemens service engineer checked the system and confirmed that the system is operating within specification.The root cause was determined to be an operator error.In order to avoid such incidents in the future, always follow the instructions given in the operator manual regarding correct patient positioning.Assessment of the reported event does not indicate a system failure or malfunction and no non-conformity was identified.The operator manual provides clear instructions to carefully monitor the patient during table movement.No further actions are to be taken as there is no negative awareness in regards to the quality and performance of the mr system.

Event Description

It was reported to siemens that an adverse event occurred while operating the magnetom symphony syngo mr system.An examination was performed on a (b)(6) male patient with a brain tumor and a low consciousness level.Following the examination, the operator removed the head coil and while the operator was turned, the patient fell from the table.The patient suffered a broken jaw which required emergency surgery.Siemens is unaware of the current state of health of the patient following surgery.

• Brand Name: MAGNETOM SYMPHONY SYNGO MR
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH- MR; henkestrasse 127; erlangen, germany 91052 ; GM 91052
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH- MR; henkestrasse 127; erlangen, germany 91052 ; GM 91052
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; 65-1a; malvern, pa ; 4486461
• MDR Report Key: 9731853
• MDR Text Key: 188483303
• Report Number: 3002808157-2020-19224
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K050199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 7104594
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/07/2020
• 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): Hospitalization; Required Intervention
• Patient Age: 90 YR