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

Model Number 10432914

Device Problem Use of Device Problem (1670)

Patient Problems Electric Shock (2554); Patient Problem/Medical Problem (2688)

Event Date 01/29/2019

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.(b)(6).

Event Description

It was reported to siemens that an adverse event occurred while servicing the magnetom aera system.On (b)(6) 2019, siemens received information that an mr operator (not a siemens service engineer) suffered an electrical shock during service on a siemens mr system.The operator was on the top of the electrical cabinet and tried to bypass the ups unit.In order to do the bypassing, the operator switched off the ups unit, but not the mr system itself.The operator unplugged the ups unit cable from the epc of the mr and touched the pins on the opened plug on the epc with his elbow resulting in an electrical shock.The operator was checked by medical staff following the incident.We are unaware of the current health status of the operator.Siemens has requested additional information in order to conduct an investigation of the reported event.

Manufacturer Narrative

Exemption number: e2017014.Siemens healthineers malvern usa (importer) is submitting the report on behalf of siemens healthcare gmbh, erlangen (manufacturer).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 france: (b)(4).

Event Description

Corrected information: based on the available event details; initial assessment of the reported problem was classified as a non-reportable event.Siemens became aware of additional information on february 28, 2019 that led to the decision to reclassify this event as a reportable event.It was reported to siemens that an adverse event occurred while servicing the magnetom aera system.On (b)(6) 2019, an mr operator (not a siemens service engineer) suffered an electrical shock during service on a siemens mr system.The operator was on the top of the electrical cabinet and tried to bypass the ups unit.In order to do the bypassing, the operator switched off the ups unit, but not the mr system itself.The operator unplugged the ups unit cable from the epc of the mr and touched the pins on the opened plug on the epc with his elbow resulting in an electrical shock.The operator was checked by medical staff following the incident.We are unaware of the current health status of the operator.Preliminary root cause investigation suggests a user error.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.The investigation showed that the error was due to a user error as a result of incorrect working steps.The operator was not trained to work on the electrics of the mr system.Only people trained on the electrics of the mr system are allowed to work on the mr cabinet.Siemens service engineers are trained that the ups will still supply parts of the system even if the mains input are disconnected at the mains box (fuse f100).Therefore, the ups must be deactivated either by pushing the epo or by switching off the ups.The plugs at the ups are rubber connectors for non-heating apparatus (iec 60320-1 type c19/20) where the pins are partly covered by a plastic housing to avoid unintentional touch.At the cabinet, plugs of type harting han c-module male/female (connector coming from ups female) are used.Again, touching live parts is very unlikely because the connector of the ups is a female type and the contacts are partly covered by the housing of the complete connector.The issue was not the result of an unsecure design of the plug.The system works as specified as the manufacturer is not considering further actions resulting from this event as no systematic error has been recognized.

• Brand Name: MAGNETOM AERA
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; henkestrasse 127; erlangen, germany 91052 ; GM 91052
• MDR Report Key: 8452242
• MDR Text Key: 139864454
• Report Number: 3002808157-2019-67427
• 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,Followup
• Report Date: 02/28/2019

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: 10432914
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/28/2019
• Event Location: Hospital
• Date Report to Manufacturer: 02/28/2019
• Date Manufacturer Received: 05/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other