MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. SYMBIA T2; GAMMA CAMERA

Model Number 10275008

Device Problem Use of Device Problem (1670)

Patient Problem Fracture, Arm (2351)

Event Date 04/28/2014

Event Type  Injury  

Event Description

A pt presented for a nuclear medicine scan with a preexisting condition; paralysis of the right arm.The pt was positioned for a brain scan.During the scan, the pt's right arm/hand moved into the path of the moving system parts.The hand/arm was caught during the movement and the radial bone in the right arm during the movement and the radial bone in the right arm was broken.There was no device failure or malfunction.The product labeling adequately instructs the users to monitor patients at all time while in motion to avoid any risk of injury.The product labeling adequately describes positioning the pt and that before system movement, the user must verify that the pt or people in the area are clear of contact, and that the system can travel without its movements being obstructed.The labeling adequately describes that the user may consider using armrest accessories to assist with arm positioning to avoid system contact.The event occurred in (b)(6).

• Brand Name: SYMBIA T2
• Type of Device: GAMMA CAMERA
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.; 2501 north barrington rd.; hoffman estates IL 60192
• Manufacturer Contact: laura meyer ; 2501 north barrington rd.; hoffman estates, IL 60192 ; 8473046022
• MDR Report Key: 3836228
• MDR Text Key: 4503045
• Report Number: 1423253-2014-00002
• Device Sequence Number: 1
• Product Code: IYX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K131634
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/28/2014

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
• Device Operator: Health Professional
• Device Model Number: 10275008
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/28/2014
• Initial Date FDA Received: 05/20/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2009
• 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
• Patient Age: 13 YR