MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH MAGNETOM SOLA; MAGNETIC RESONANCE DIAGNOSTIC DEVICE

Model Number	11291455
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Patient Problem/Medical Problem (2688)
Date of Event	06/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported events.As this event is under investigation, a final root cause has not yet been determined.A supplement report will be filed upon completion of the investigation.Internal id # (b)(4).
Event or Problem Description
Siemens was notified about an incident that occurred on the magnetom sola system.Patient was positioned headfirst on the table and completed her cervical and thoracic spine studies.As the patient was being removed from the bore of the mri machine, the patient screamed.The patient informed the technologist that her shoulder hurt.The patient was then placed in the wheelchair and left the facility.Later the patient had follow-up x-rays that showed she had an impacted humerus fracture.Siemens was not provided details of the aftercare of the patient once she left the medical facility.
Additional Manufacturer Narrative
Per the complaint report, siemens is unaware of a serious injury associated with this issue.Patient was having a mri of the cervical and thoracic scan.Patient was positioned headfirst on the table and completed her cervical and thoracic spine studies, as the patient was being removed from the bore of the mri the patient screamed.The technologist asked her what was the problem and she said that her shoulder hurt.The technologist placed the patient in the patient's wheelchair and the patient left the facility.It was reported that no medical intervention was necessary.The customer states that the patient later had x-rays that showed she had an impacted humerus fracture and reported those findings to them through a lawyer a few weeks later.The customer did not provide any additional details of the aftercare of the patient once she left their facility.With the provided information we conclude that this issue was not caused by a technical deviation of the mr system.No detailed information on the course of the incident was provided.The event was classified as operator mistake.Therefore, we recommend training of the operator staff once again.The operator manual provides clear instructions to carefully monitor the patient during table movement.

• Brand Name: MAGNETOM SOLA
• Common Device Name: MAGNETIC RESONANCE DIAGNOSTIC DEVICE
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; henkesstrasse 127; erlangen 91052 ; GM 91052
• MDR Report Key: 10240652
• Report Number: 3002808157-2020-36316
• Device Sequence Number: 2679458
• Product Code: LNH
• UDI-Device Identifier: 04056869164809
• UDI-Public: 04056869164809
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K182129
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 11291455
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/24/2020
• Supplement Date Received by Manufacturer: 07/30/2020
• Initial Report FDA Received Date: 07/07/2020
• Supplement Report FDA Received Date: 07/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other