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

Model Number	10046733
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Device Handling Problem (3265)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Damage to Ligament(s) (1952)
Date of Event	08/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to siemens that an adverse event occurred while operating the somatom perspective (de) ct system.An 81-year-old female patient was taken to the hospital's emergency department on (b)(6) 2023, because she reportedly ¿fell sick that day and suddenly fell down¿.She was diagnosed with a covid-19 infection and several ct examinations were planned; face, brain, and lower extremities, as well as abdomen and chest.During the last examination (abdomen and chest), the patient's left arm broke through the plexi-ring of the ct portal (scan window).As a result, the patient suffered a bone fracture of her left forearm as well as soft tissue damage including nerves and fingers.The patient underwent surgery in the hospital after the incident and is recovering in the intensive care unit.This report is submitted with an abundance of caution.
Additional Manufacturer Narrative
According to the available information, the patient was not fixed and was advised not to move.She was positioned in head-first scan direction for scanning the abdomen or chest, and her arms were placed on the head arm support cushion.According to the owner¿s manual (instructions for use), the patient should always be observed during all system movements and the operator should press the stop key in urgent situations.Siemens healthineers is conducting a thorough investigation of the reported event.Should the investigation identify a general design, systematic issue, or any other reason as a root cause of this issue, a supplemental report will be filed.Based on the available information the system worked as specified.
Additional Manufacturer Narrative
On august 22, 2023, siemens healthineers became aware of additional information that the patient's thumb was amputated due to the reported injury.The patient is still under care at the hospital and has undergone a second surgery.The technical investigation is still ongoing.

• Brand Name: SOMATOM PERSPECTIVE
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstrasse 1~or; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemensstrasse 1~or; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; malvern, PA 19355 ; 4843231631
• MDR Report Key: 17642363
• Report Number: 3004977335-2023-00102
• Device Sequence Number: 14850644
• Product Code: JAK
• UDI-Device Identifier: 04056869013039
• UDI-Public: 04056869013039
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K183548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: 10046733
• Device Catalogue Number: 10046733
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2023
• Supplement Date Received by Manufacturer: 08/22/2023
• Initial Report FDA Received Date: 08/29/2023
• Supplement Report FDA Received Date: 09/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female