MAUDE Adverse Event Report: SIEMENS AG / SIEMENS HEALTHCARE GMBH SIEMENS MMR (MRI/PET SCANNER); TOMOGRAPHIC IMAGES COMBINING EMISSION

Model Number MMR

Device Problems Loss of Power (1475); Smoking (1585); Electrical Shorting (2926)

Patient Problem No Code Available (3191)

Event Date 04/23/2018

Event Type  Injury  

Event Description

After one hour of study the pet/mri machine stopped unexpectedly and smoke filled the scanner room.The participant was taken out of the scanner immediately and taken to a safe area.Pt denied any smoke inhalation while in the scanner.He smelled the smoke while walking out of the scanner for 1-2 seconds.It turns out that the gradient coil in the mr scanner shorted out, sparked, and soot covered the inner fascia of the scanner.Smoke filled the room and the fire dept was called.

• Brand Name: SIEMENS MMR (MRI/PET SCANNER)
• Type of Device: TOMOGRAPHIC IMAGES COMBINING EMISSION
• Manufacturer (Section D): SIEMENS AG / SIEMENS HEALTHCARE GMBH
• MDR Report Key: 7482462
• MDR Text Key: 107332214
• Report Number: MW5076995
• 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: Other Caregivers
• Type of Report: Initial
• Report Date: 05/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MMR
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 34 YR
• Patient Weight: 95