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

Model Number 10018223

Device Problem Protective Measures Problem (3015)

Patient Problem Bone Fracture(s) (1870)

Event Date 11/16/2022

Event Type  Injury  

Manufacturer Narrative

Siemens attempted to initiate a detailed investigation of the reported incident; however, it was reported that the incident save logs were not available for investigation.Furthermore, additional patient health status information and event details will not be made available to siemens.According to an authorized service provider, the system showed no errors at the time of the event.The service provider reported that an obstruction test on longitudinal table movement into bore was performed with the following results: the table drive power was interrupted, and the table stopped when obstructed.The event and available information will be reviewed by a siemens expert.A supplemental report will be submitted if additional information is received upon conclusion of the expert review.

Event Description

It was reported that while using the hologic breast coil during a patient examination the table did not stop while moving into the bore.This issue resulted in compression of the patient and broken ribs.A total of six (6) ribs were broken, three (3) on each side.The system showed no errors at the time of the event.An obstruction test on longitudinal table movement into bore was performed with the following results: the table drive power was interrupted, and the table stopped when obstructed.

Manufacturer Narrative

H10 manufacturer narrative: h3, h6: siemens healthineers completed the investigation of the complaint issue.The complaint alleged that while using the hologic breast coil during a patient examination the table did not stop while moving into the bore.This issue resulted in compression of the patient and broken ribs.A total of six (6) ribs were broken, three (3) on each side.The system showed no errors at the time of the event.An obstruction test on longitudinal table movement into bore was performed with the following results: the table drive power was interrupted, and the table stopped when obstructed.Due to the lack of information the root cause for this incident could not be determined.However, the system was found to be in specification.Per the complaint report it was stated that the system showed no errors at the time of the event.An obstruction test on longitudinal table movement into bore was successfully performed by the servicing third-party company.It was confirmed that the system was in specification.On 2022-11-29 siemens healthineers requested details regarding the injury of the patient, the medical treatment of the injury, details of the used sentinelle breast coil and a save log to fully investigate this incident.As per additional information received by siemens healthineers, the customer stated that there was save log but explained that he was not able to transfer the save log to a usb stick.Therefore, our local customer service engineer (cse) tried to obtain the save log.It was then that the cse could not find the concerned save log.The analysis of the respective save log is elementary to understand the order of events which could have led to this unfortunate incident because events during the workflow are logged accordingly.The customer declined providing any details regarding the affected sentinelle breast coil.An analysis of the data base showed that no sentinelle breast coil is registered with any of the mri systems the customer owns.It is unclear whether the sentinelle breast coil in question was purchased through siemens healthineers or a different supplier.Despite three attempts, siemens was informed that the customer denies providing any more information about the patient injury, the current health status of the patient, any medical treatment or details regarding the affected local coil or any other data for an investigation.Due to the lack of information, siemens had to discontinue the investigation and close the complaint.To prevent an injury to the patient or other persons or damage to the table there are several buttons available which stop table movement immediately.Those buttons are located directly on the mri system and in the control room.The operator manual magnetom symphony a tim system provides detailed instructions of the locations and exact function of these buttons.The patient must always be kept under visual or acoustic observation during an examination.H11 corrected data: d3: device was serviced by a third party.This field should have been checked "yes" in the initial report submitted to the fda on december 16, 2022.

• Brand Name: MAGNETOM SYMPHONY A TIM
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH - MR; henkestrasse 127; erlangen, 91052 ; GM 91052
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH - MR; henkestrasse 127; erlangen, 91052 ; GM 91052
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 15997153
• MDR Text Key: 305622444
• Report Number: 3002808157-2022-54760
• Device Sequence Number: 1
• Product Code: LNH
• UDI-Device Identifier: 04056869020471
• UDI-Public: 04056869020471
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123938
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10018223
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other