MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. BIOGRAPH VISION 450 (6R/EDGE); SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION

Catalog Number	10749671
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Crushing Injury (1797); Laceration(s) (1946)
Date of Event	03/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Siemens medical solutions usa, inc.Was notified on march 8, 2024, of a customer service engineer injury that occurred on (b)(6) 2024.A permanent finger injury was sustained while servicing the device contrary to the service instructions.There are no product defects or failures.There are no labeling defects.There were no other injuries to any other persons.

• Brand Name: BIOGRAPH VISION 450 (6R/EDGE)
• 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: 18989528
• Report Number: 1423253-2024-00002
• Device Sequence Number: 15520056
• Product Code: KPS
• UDI-Device Identifier: 04056869238081
• UDI-Public: (01)04056869238081
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• 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 Catalogue Number: 10749671
• 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: 03/27/2024
• Supplement Report FDA Received Date: 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 34 YR
• Patient Sex: Male