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

Catalog Number 10749671

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Crushing Injury (1797); Laceration(s) (1946)

Event Date 03/08/2024

Event Type  Injury  

Event 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)
• Type of Device: 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
• MDR Text Key: 338740312
• Report Number: 1423253-2024-00002
• Device Sequence Number: 1
• Product Code: KPS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 10749671
• Date Manufacturer Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2021
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 34 YR
• Patient Sex: Male