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

Model Number 10432915

Device Problems Use of Device Problem (1670); Human-Device Interface Problem (2949)

Patient Problems Abrasion (1689); Injury (2348); Patient Problem/Medical Problem (2688)

Event Date 03/22/2019

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.This event occurred in (b)(6).

Event Description

It was reported to siemens that an adverse event occurred while operating the magnetom skyra system.While the operator was positioning the patient for a head examination, an oxygen cylinder was brought into the magnet room.The oxygen cylinder was attracted to the magnet resulting in an injury to the patient.The patient suffered a large skin abrasion to the back.An x-ray was performed and no further injuries were found.The health status of the patient is unknown at this time.Siemens has requested additional information in order to conduct an investigation of the reported event.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.The root cause was determined to be a user error.While the operator was positioning the patient for a head examination, an oxygen cylinder was brought into the magnet room resulting in injury to the patient.Information was provided that the patient has healed and no further medical treatment is needed.The investigation concludes that the cause of this event was 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.The corresponding magnetom operator manual and the magnetom system owner manual 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 ferromagnetic 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 (magnet room).No further actions are to be taken as there is no negative awareness in regards to the quality and performance of the mr system.

• Brand Name: MAGNETOM SKYRA
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; henkestrasse 127; erlangen, germany 91052 ; GM 91052
• MDR Report Key: 8451997
• MDR Text Key: 139855778
• Report Number: 3002808157-2019-74993
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• PMA/PMN Number: K173592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 03/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10432915
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 34 YR
• Patient Weight: 65