MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. SYMBIA S NUCLEAR MEDICINE IMAGING CAMERA; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number 8717741

Device Problem Unintended Movement (3026)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 05/02/2022

Event Type  Injury  

Event Description

Acquiring an auto xe study on siemens camera and during the perfusion phase the camera was rotating to rao position and detector 1 came down on patients right elbow.Patient yelled arm was being crushed.I pushed the release button on bed to stop detector, called for help and (b)(6) retracted the bed manually.The patients elbow had indention marks and was sore to touch.Fda safety report id# (b)(4).

• Brand Name: SYMBIA S NUCLEAR MEDICINE IMAGING CAMERA
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.
• MDR Report Key: 14429980
• MDR Text Key: 292033856
• Report Number: MW5109756
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8717741
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 109 KG
• Patient Ethnicity: Hispanic
• Patient Race: White