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

Model Number 11060815

Device Problem Use of Device Problem (1670)

Patient Problems Burn, Thermal (2530); Patient Problem/Medical Problem (2688)

Event Date 12/18/2018

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 vida system.The user reported that a patient complained about heating during a breast examination.An area of redness was detected after the examination which subsided before the patient was released.The following day the patient contacted the user and reported a blister.The severity of the injury and what medical treatment was provided, if any, is not known at this time.Siemens has requested additional information in order to conduct an investigation.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.Assessment of the log files does not indicate a system failure or malfunction and no non-conformity was identified.During investigation siemens became aware that the site physician examined the patient and determined that the patient did not suffer a burn and diagnosed the patient with a skin condition called ehlors-danlos syndrome.Additionally, our experts analyzed the images and data generated during the patients' examination.A questionnaire regarding heating and burning issues was requested but not provided by the customer.The complete examination of the patient's breast lasted 75.5 min with an active scanning time of 65.1 min.No abnormality was found which would indicate a system malfunction.The complete measurement was performed in the normal operating mode.Contrast agent was given.The sar values were within the limits defined by the mr safety standard (iec 60601-2-33), i.E.The maximum applied sar was 79% of the normal mode limit.The applied rf in this case should not represent a risk under normal circumstances and scan conditions.Furthermore, the patient absorbed 86.4 wmin/kg which is below the limit of 240 wmin/kg defined in the mr safety standard (iec 60601-2-33).It is well known that patients react differently to rf exposure, i.E.Some persons may feel heating sensations where others may not.Therefore, there is reason to believe that the complained issue may be related to the individual sensitivity of the patient and multiple additional factors (contrast agent, ehlors-danlos syndrome, and intensive examination in terms of duration and applied rf in relation to patient age).According to the site physicist the blisters are not related to a burn but to a skin condition called ehlors-danlos syndrome.No hardware or software problem was found which would explain the reported redness of the patient and the system works as specified.

• Brand Name: MAGNETOM VIDA
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; henkestrasse 127; erlangen, germany 91052 ; GM 91052
• MDR Report Key: 8482561
• MDR Text Key: 140903362
• Report Number: 3002808157-2019-62660
• Device Sequence Number: 1
• Product Code: LNH
• Combination Product (y/n): N
• PMA/PMN Number: K170396
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 12/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 11060815
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/18/2018
• Event Location: Hospital
• Date Report to Manufacturer: 12/18/2018
• Initial Date Manufacturer Received: 12/18/2018
• Initial Date FDA Received: 04/04/2019
• Supplement Dates Manufacturer Received: 05/14/2019
• Supplement Dates FDA Received: 05/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 76 YR
• Patient Weight: 73