MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. SYMBIA INTEVO 6; SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION

Model Number	10764803
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	06/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Siemens medical solutions usa, inc.Was notified on march 11, 2024, of a customer service engineer injury that occurred on (b)(6) 2023.Allegedly, the engineer fractured his finger while servicing the device contrary to the service instructions.No labeling or product defects were found.

• Brand Name: SYMBIA INTEVO 6
• Common Device Name: SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.; 2501 n. barrington rd.; hoffman estates IL 60192
• Manufacturer (Section G): SIEMENS MEDICAL SOLUTIONS USA, INC.; 2501 n. barrington rd.; hoffman estates IL 60192
• Manufacturer Contact: laura meyer ; 2501 n. barrington rd.; hoffman estates, IL 60192 ; 8472172734
• MDR Report Key: 19083376
• Report Number: 1423253-2024-00003
• Device Sequence Number: 8248674
• Product Code: KPS
• UDI-Device Identifier: 04056869001234
• UDI-Public: (01)04056869001234(21)2004
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K200474
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2024

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: Other
• Device Model Number: 10764803
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/10/2024
• Supplement Report FDA Received Date: 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male