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

Model Number 129172

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem Head Injury (1879)

Event Date 02/06/2014

Event Type  malfunction  

Event Description

Molding on the mri scanner fell off during exam and hit the patient on the head.

• Brand Name: MAGNETOM HARMONY MRI SCANNER
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS, USA, INC.; 51 valley stream parkway; malvern PA 19355
• MDR Report Key: 3775172
• MDR Text Key: 4438784
• Report Number: 3775172
• Device Sequence Number: 1
• Product Code: LNH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 03/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Model Number: 129172
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/27/2014
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 04/28/2014
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 66