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

Model Number	10430603
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	09/17/2020
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 the bed rail used for the system accessories fell off and hit the patient's lower body (legs).The patient sustained moderate injuries which required medical treatment, however, the details regarding the type of injuries, medical treatment provided, and patient's current health status were not provided to siemens as of the date of this report.
Event or Problem Description
Additional event information and clarification: additional information from the facility reported that an assisting person, not the patient, who was slightly injured during the reported event.The injured assistant was offered medical treatment but declined.The patient's assistant was helping the patient off the table to a stretcher and the stretcher was caught under the table as the table was being lowered, causing the side rail of the table to break off.The side rail fell onto the assistant's foot.
Additional Manufacturer Narrative
Manufacturer narrative: h3; h4: siemens completed the technical investigation of the reported event.The root cause of the event was use error due to the stretcher being positioned under the table as it was being lowered.This resulted in the side rail being broken off and falling.Clinical engineering repaired the side rail and the table is now functional.Additional action is not warranted at this time.

• Brand Name: SOMATOM DEFINITION FLASH
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• MDR Report Key: 10683118
• Report Number: 3004977335-2020-48403
• Device Sequence Number: 3450074
• Product Code: JAK
• UDI-Device Identifier: 04056869006963
• UDI-Public: 04056869006963
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 11/24/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 10430603
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/17/2020
• Supplement Date Received by Manufacturer: 11/20/2020
• Initial Report FDA Received Date: 10/15/2020
• Supplement Report FDA Received Date: 11/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention