MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH SOMATOM DEFINITION EDGE; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number	10590000
Medical Device Problem Codes	Component Missing (2306); Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens has initiated a technical investigation of the reported event.The root cause has not been identified.A supplemental report will be submitted upon the completion of the investigation.
Event or Problem Description
It was reported to siemens that during the table movement of the somatom definition edge nexaris system (combination of ct scanner and angio c-arm), the tabletop dislocated from the table support due to missing screws.At the time of the event, a ct phantom was placed on the table and there was no patient involvement.No injury to the user or others was reported.The system had been recently installed and the siemens application support specialist was onsite to train the customer.This event is being reported with an abundance of caution.
Additional Manufacturer Narrative
Siemens completed a technical investigation of the reported event.An isolated working error during installation was confirmed by the technical investigator (root cause).The installation instruction (document ct00-000.812.01) has been checked and was found appropriate.The worker was identified and trained again.Since no systematic issue has been identified, no preventive action has been initiated.

• Brand Name: SOMATOM DEFINITION EDGE
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• MDR Report Key: 10502866
• Report Number: 3004977335-2020-41961
• Device Sequence Number: 19628659
• Product Code: JAK
• UDI-Device Identifier: 04056869006949
• UDI-Public: 04056869006949
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K190578
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2020

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
• Operator of Device: Health Professional
• Device Model Number: 10590000
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/11/2020
• Supplement Date Received by Manufacturer: 10/06/2020
• Initial Report FDA Received Date: 09/08/2020
• Supplement Report FDA Received Date: 10/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1