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

Model Number 11344916

Device Problem Use of Device Problem (1670)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 07/16/2023

Event Type  Injury  

Manufacturer Narrative

B1, b2, b5, h1: the customer did not provide siemens with enough information regarding the event or nature and extent of the report of "injury".Siemens is conservatively reporting this event as a serious injury, although additional information from the customer is still pending receipt by siemens as of the date of this report.H3, h6: as of the date of this report, the details of the event are unclear, and it is not known whether or not the reported device will be made available for investigation.The codes entered in section h3 are based on a worst-case scenario only, with the assumption the iv pole became stuck to the mr magnet due to use error.A supplemental report will be submitted upon receipt of additional event and device information.

Event Description

The customer initially reported that an iv pole became stuck to the mr magnet.In response to an email from siemens requesting additional information regarding the event and potential injury, the customer responded by email on (b)(6), 2023, stating "yes" in response to the question "did an injury occur?".The customer stated they would not disclose additional information regarding the nature and severity of the injury, need for medical intervention, current health status of the injured person, or additional event details, and that siemens should contact the risk manager.Although additional attempts have been made by siemens to obtain this information from the risk manager, a response has not been received by siemens as of the date of this report.Due to the unknown nature and severity of the injury, siemens decided to perform an "in doubt" reporting of this event.

• Brand Name: MAGNETOM LUMINA
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; henkestrasse 127; erlangen 91052 ; GM 91052
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; henkestrasse 127; erlangen 91052 ; GM 91052
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd., mc 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 17546159
• MDR Text Key: 321175145
• Report Number: 3002808157-2023-00009
• Device Sequence Number: 1
• Product Code: LNH
• UDI-Device Identifier: 04056869230740
• UDI-Public: 04056869230740
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K220939
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 11344916
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other