MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. MAGNETOM VERIO; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Model Number 10276755

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Head Injury (1879)

Event Date 06/07/2018

Event Type  malfunction  

Event Description

Patient stopped exam during first picture to say something "snapped on her head".Patient moved causing the head band piece of the headphones to separate from the ear piece.The head piece slipped off and 'snapped' on the side of her head.Manufacturer response for mri headset, magnetom verio (per site reporter).Reviewing.

• Brand Name: MAGNETOM VERIO
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.; 40 liberty boulevard; mailcode: 65-1a; malvern PA 19355
• MDR Report Key: 7726174
• MDR Text Key: 115231292
• Report Number: 7726174
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 10276755
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/05/2018
• Event Location: Hospital
• Date Report to Manufacturer: 07/27/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 8395 DA