MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. C.CAM IMAGING; GAMMA CAMERA

Model Number 08419009

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Damage to Ligament(s) (1952)

Event Date 12/03/2021

Event Type  Injury  

Event Description

It was reported to siemens medical solutions usa inc., on may 9, 2023, that during the rest portion of a cardiac scan performed on (b)(6) 2021, a patient neglected to follow the user-provided safety briefing/instructions and moved their leg out of the scanning area.The device performed as expected and stopped motion upon contact.The treadmill exercise and stress portion of the scan were then completed.On (b)(6) 2023, this patient subsequently reported a serious injury to their knee.Siemens medical solutions usa inc.Is unable to substantiate or confirm the sequence of events as the alleged incident occurred on (b)(6) 2021 and was not reported to the manufacturer until 2023.Based on device design and technical device information, the device is highly unlikely to have caused or contributed to the reported injury.The described scan, workflow, and sequence of events also make it highly unlikely that the device caused or contributed to a serious injury event.A radiological assessment cannot be conducted by the manufacturer.There are no product defects or failures.There are no labeling defects.There were no other injuries to any other persons reported.

• Brand Name: C.CAM IMAGING
• Type of Device: GAMMA CAMERA
• 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: 17088225
• MDR Text Key: 316855617
• Report Number: 1423253-2023-00001
• Device Sequence Number: 1
• Product Code: KPS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031825
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 08419009
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention