MAUDE Adverse Event Report: MAGNETOM C!; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number 10019418

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Limb Fracture (4518)

Event Date 09/12/2021

Event Type  Injury  

Manufacturer Narrative

Siemens is conducting a thorough investigation of the reported events.As this event is under investigation, a root cause has not yet been determined.A supplement report will be filed upon completion of the investigation.

Event Description

It was reported to siemens that an adverse occurred while operating the magnetom c! system.After completing an exam, the patient was moving down from the patient table by placing his feet on a small stool.The patient placed one foot on the stool and when leaning on the patient table the table moved and he lost his balance and fell.The patient suffered a wrist fracture and was treated in the hospital for two days before being released.Siemens has requested additional information in order to conduct an investigation of the reported event.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.The root cause was determined to be a user error.After completing an exam, the patient was moving down from the patient table by placing his feet on a small stool.The patient placed one foot on the stool and when leaning on the patient table, he lost his balance and fell.The wooden stool is not part of the mr system.The operators manual contains a warning message regarding getting off the patient table.No further actions are to be taken as there is no negative awareness regarding the quality and performance of the system.The mr system works as specified and the event is considered an operator error.

• Brand Name: MAGNETOM C!
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• MDR Report Key: 12480287
• MDR Text Key: 271651210
• Report Number: 3004754211-2021-97120
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• PMA/PMN Number: K082331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 09/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10019418
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/03/2021
• 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): Hospitalization