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

Model Number 7391167

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/20/2022

Event Type  malfunction  

Manufacturer Narrative

Siemens is conducting a thorough investigation of the reported events.As this event is under investigation, a root cause has not yet been determined.A supplement report will be filed upon completion of the investigation.

Event Description

It was reported to siemens that a malfunction occurred while operating the magnetom avanto system.While moving a patient from the mr exam room to the mr icu area, a mechanical component inside the mr trolley table top latching system failed causing the trolley table top latches to unexpectedly release.The table top came off of the trolley with the patient on the table and fell to the floor.No reported injuries are known.Siemens has requested additional information in order to conduct an investigation of the reported event.

Manufacturer Narrative

Siemens could not complete the investigation of the reported event and system because additional information was not provided by the facility.A root cause could not be identified.Further action by siemens is not possible.This complaint will be closed.

Manufacturer Narrative

D9: device was available for evaluation and should have been checked "yes." h3: device was evaluated by manufacturer.H6: coding has been corrected.H10: it was reported to us the tabletop came of the trolley with the patient on the table.The patient was not injured.A mechanical component inside the mr trolley tabletop latching system failed after the trolley with patient on the trolley tabletop was moved from the mr exam room to the mr icu area.Trolley tabletop latches un-expectingly released and patient and tabletop fell to the floor.As no further information has been received an in-doubt reporting was performed.Bu root cause analysis:: our experts investigated the complained issue.The analysis of the eventlog shows various error messages during the vertical movement of the patient table and the patient transfer between trolley and mr system: the patient table was not correctly adjusted to the trolley.The removable plate was disconnected from the carrier plate without vertical motor movement of the patient table.The removable plate was not lying correctly on the carrier plate.Some errors were reported at the same time, so that the cause can be either incorrect adjustment or manual intervention.As a result, it could come during the transfer to an incorrect transfer of the removeable tabletop on the trolley, so that the removable tabletop was not securely locked on the trolley.Therefore, the removable plate tilt forward from the trolley.The cause is not due to a defect in the patient table, but either to an incorrect adjustment and/or an operator error.Investigation conclusion: the system functioned within specifications and no malfunction was identified.The root cause is user error.The user should always check adjustments of the patient table transfer system.Manual removement of the removable tabletop from the carrier plate is strongly discouraged.A transfer may only be carried out as described in the system instructions for use.

• Brand Name: MAGNETOM AVANTO
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH - MR; henkestrasse 127; erlangen, germany 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: 13549398
• MDR Text Key: 291240709
• Report Number: 3002808157-2022-13798
• Device Sequence Number: 1
• Product Code: LNH
• UDI-Device Identifier: 04056869006611
• UDI-Public: 04056869006611
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7391167
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/20/2022
• Initial Date FDA Received: 02/17/2022
• Supplement Dates Manufacturer Received: 06/30/2022; 06/30/2022
• Supplement Dates FDA Received: 07/01/2022; 07/07/2022
• 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