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

Model Number	10432914
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	10/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1: the reporting facility phone number is (b)(6).H3, h6: siemens healthineers has initiated an investigation of the reported event.The investigation is ongoing.A supplemental report will be submitted if additional information is obtained upon the completion of the investigation.H6: code 4756 was utilized for component code because not enough information was provided to siemens to determine what component, if any, was involved in the reported complaint event.
Event or Problem Description
Siemens healthineers was informed that ta patient sustained a burn on their hand during a lumbar spine examination.Furthermore, several patients complained about a heating sensation during examination.Per the complaint report siemens is unaware of a serious injury associated with this issue.Although requested, no additional information has been received by siemens regarding the severity of the patient's injury or the other patients who complained of a heating sensation.
Additional Manufacturer Narrative
Siemens has completed an investigation of the event.Assessment does not indicate a system failure or malfunction and no non-conformity was identified.In the original complaint description, it was stated that a patient had sustained a burn on his hand during a lumbar examination and pictures of the burn were attached.However, during investigation it was determined that this information belonged to an older complaint from the same customer and the same system from 2021.It was confirmed by the customer that the current complaint was not about a burn on the hand, but about multiple patients sweating.None of these patients sustained a burn and the pictures of the older complaint from 2021 had been sent by mistake.The data available does not contain sufficient information to start an investigation.We were made aware on january 5, 2024, by e-mail from the local service engineer that the customer was not able to provide the exact date or time of the occurrences and identify the patients who had complained about the heat / sweating.Therefore, no necessary data could be provided, and no investigation was possible.The qa testing for all coils used passed.It was also stated that the customer had problems with the air conditioning in the examination room and that the week of the occurrences was one of the hottest weeks at the site in that year.After the responsible technicians had fixed the customer's air conditioning, there were no further occurrences.Thus, we conclude that the issue might have been caused by the combination of a defective air-conditioning and high room temperatures due to the local weather.No further actions are to be taken as there is no negative awareness regarding the quality and performance of the mr system.
Additional Manufacturer Narrative
G2: report source foreign was added.H11: corrected data: d4: complete udi number added.H11: corrected data: d4: complete udi number added.

• Brand Name: MAGNETOM AERA
• Common Device Name: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; henkestrasse 127; erlangen 91052 ; GM 91052
• Manufacturer (Section G): SIEMENS HEALTHINEERS AG; allee am röthelheimpark 2; or rittigfeld 1; erlangen 91052 ; GM 91052
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd., mc 65-1a; malvern, PA 19355 ; 8483234198
• MDR Report Key: 18193645
• Report Number: 3002808157-2023-00015
• Device Sequence Number: 7715305
• Product Code: LNH
• UDI-Device Identifier: 04056869006697
• UDI-Public: (01)04056869006697(21)41239
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K231560
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/17/2024

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: 10432914
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2023
• Supplement Date Received by Manufacturer: Not provided; 07/17/2024
• Initial Report FDA Received Date: 11/22/2023
• Supplement Report FDA Received Date: 04/26/2024; 07/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown