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

Model Number 10849583

Device Problem Insufficient Information (3190)

Patient Problems Laceration(s) (1946); Injury (2348); Suture Abrasion (2497)

Event Date 02/16/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Siemens is conducting a thorough investigation of the reported events.As this event is under investigation, a root cause has not yet been determined.A supplement report will be filed upon completion of the investigation.

Event Description

It was reported to siemens that an adverse event occurred while operating the magnetom prisma fit system.While setting up for an experiment, a high intensity focused ultrasound matching box was placed on the exam room floor.When a student was picking up the device to place it on a cart, the device was brought too close to the magnet.The hifu matching box was drawn to the front of the mr system resulting in an injury to the students hand.The severity of the injury is not known, however, it was reported the student received a cut on the lower thumb joint which required stitches and a bruised finger.Additional details have been requested from the site and have not yet been provided.There was no patient involved in this event and we are unaware of any other impact to the state of health of any persons involved.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.The root cause was determined to be the introduction of ferromagnetic pieces into the mr examination room and therefore a user error.Due to the strong magnetic field, particular safety measures have to be adhered to in order to prevent injuries.Therefore, the magnetom prisma/prisma fit operator manual - mr system syngo mr e11 section 2 and the magnetom prisma/prisma fit system owner manual section 1 provide clear instructions and warnings regarding both magnetic field hazards and training of personnel with regards to mr safety.The responsibility to instruct personnel and patients who have access to the mr examination room about magnetic field hazards lies with the customer.The manuals state that only equipment specified or recommended for use in the controlled area (mr examination room) shall be used.The introduction of magnetic objects into the magnetic field is contrary to the statements given in the operating instructions.Furthermore, special warning signs are posted at the entrance of the controlled access area.The manufacturer is not considering further actions resulting from this event as no systematic error has been recognized.

• Brand Name: MAGNETOM PRISMA FIT
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; henkestrasse 127; erlangen, 91052 ; GM 91052
• MDR Report Key: 7315756
• MDR Text Key: 101570681
• Report Number: 3002808157-2018-17848
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• PMA/PMN Number: K132119
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 02/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10849583
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/16/2018
• Event Location: Hospital
• Date Report to Manufacturer: 02/16/2018
• Date Manufacturer Received: 11/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 30 YR
• Patient Weight: 73