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

Model Number 10432914

Device Problems Use of Device Problem (1670); Human-Device Interface Problem (2949); Inadequate User Interface (2958)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 12/13/2018

Event Type  Injury  

Manufacturer Narrative

Siemens healthineers has requested but hasn't received any additional details from the hospital.

Event Description

According to the information provided to siemens healthineers by the hospital, a patient was injured during a scan involving siemens healthineers magnetom aera device.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.Assessment does not indicate a system failure or malfunction and no non-conformity was identified.According to information provided by the director of the hospital, the patient scan was never started.Therefore, it was not possible to investigate any dicom images.Siemens did not receive any further information about patient injuries after several requests for information.A log file was received and the sequence of events regarding table movements was reconstructed based on the analysis of the event log.The center button was pressed at the cabin user interface, which is located on the front of the system next to the table and the table started to move.Pushing the center button triggers a target drive, and the tabletop moves automatically into the bore to its target position according to its previously set parameter.While the table was moving, a position update of the table was logged.The center button was then pushed twice before the table stopped with the table error message "109 patient table error: error horizontal movement.Check for obstacles and try again.If the problem persists, please call siemens service." despite the error message, the center button was pushed two more times.Following the table error message, the operator tried to reset the error message on the cabin user interface and tried to move the table out of the bore multiple times ('key pressed' and 'turbo key pressed').Within 3 seconds, the emergency stop button was pressed at the intercom from the adjacent room.Approximately 25 seconds afterward, the operator attempted to move the table out of the bore multiple times by pressing the corresponding key and turbo key.Due to the activation of the emergency stop, the table is locked and can no longer be moved by pressing these keys.After another 30 seconds, the table was unlocked from the intercom.After the table was unlocked the operator pressed the center button again to move the table to its target position.The table stopped a second time with the identical error message.After unlocking the table for a second time the table was moved into the bore manually by pushing the drive in button until the table reached the desired position.The table logged that the z-axis target had been reached.Information was provided that padding was removed from the table at a point in time and the technician put a thin hospital blanket over the metal plate on the table.A metal plate on the table as described is not part of the mr system.The construction of the table and bore is designed in such a way that the tabletop can never move vertically when it has entered the magnet.The patients described feeling of being crushed during the time the table was in the bore was not caused by the mr system.Siemens confirms that the system did not malfunction and works as specified.Instructions for use of the mr system regarding suitability of the patient to be examined, compatibility of third-party products, and positioning the patient and securing the coils are provided in the magnetom family, owner manual, mr system, syngo mr e11.Furthermore, it is in the responsibility of the treating physician and trained medical personnel to ensure that the patient meets all the requirements to be scanned safely by following the instructions of the corresponding manuals.

• Brand Name: MAGNETOM AERA
• Type of Device: MAGNETIC RESONANCE DIAGNOSTIC DEVICE
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; henkesstrasse 127; erlangen 91052 ; GM 91052
• MDR Report Key: 10376365
• MDR Text Key: 202180160
• Report Number: 3002808157-2020-38130
• Device Sequence Number: 1
• Product Code: LNH
• UDI-Device Identifier: 04056869006697
• UDI-Public: 04056869006697
• Combination Product (y/n): N
• PMA/PMN Number: K163312
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 10432914
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other