MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH MAGNETOM PRISMA; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Device Problems Improper or Incorrect Procedure or Method (2017); Appropriate Term/Code Not Available (3191)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 05/05/2016

Event Type  Injury  

Manufacturer Narrative

The device was evaluated and was found to be operating within specification.The system operators manual clearly warns of the introduction of ferrous objects to the examination room.This event occurred in (b)(6): (b)(6).

Event Description

It was reported to siemens that while scanning a pediatric patient on the magnetom prisma, the childs parent brought a ferrous metal chair into the scan room.The chair was drawn to the magnet and collided with the childs head.The child was evaluated by the attending physician and did not suffer any bone fractures, however, the child did have moderate bleeding from the nose.Siemens is unaware of any follow up medical treatment.The mr suite has two entrances, both of which are labeled with warning signs regarding the introduction of magnetic materials to the examination room.

• Brand Name: MAGNETOM PRISMA
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; allee am roethelheimpark 2; erlangen, 91052 ; GM 91052
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; allee am roethelheimpark 2; erlangen, 91052 ; GM 91052
• Manufacturer Contact: meredith adams ; 40 liberty blvd; 65-1a; malvern, PA 19355 ; 6104486461
• MDR Report Key: 5684611
• MDR Text Key: 46075744
• Report Number: 2240869-2016-02717
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K132119
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 05/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 5 YR