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

Model Number 10849582

Device Problem Use of Device Problem (1670)

Patient Problems Burn(s) (1757); Injury (2348)

Event Date 04/10/2019

Event Type  Injury  

Manufacturer Narrative

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 following an examination on the magnetom prisma system.The customer reported that the peru unit was extremely hot to the touch after 1.5 hours of scanning a patient.The patient suffered blisters on the upper left side of the arm.At this time, the size and severity of the blisters are unknown and it was not reported if medical treatment was necessary.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.Assessment of the log files does not indicate a system failure or malfunction and no non-conformity was identified.The complete fmri examination of the volunteer patient lasted 87,8 min with an active scanning time of 75,1 min.No abnormality was found which would indicate a system malfunction.The complete measurement was performed in the normal operating mode.The sar values were within the limits defined by the mr safety standard (iec (b)(4)), i.E.The maximum applied sar was 23% 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 7,0 wmin/kg which is clearly below the limit of 240 wmin/kg defined in the mr safety standard (iec (b)(4)).The ecg peru has been replaced and evaluated and no issues were found.The peru showed no problems during test.There was a visible deformation of the battery, however testing was okay.The battery was replaced, and the deformed battery was sent to the supplier for further analysis.The supplier checked the charging and discharging characteristics of the battery as well as the capacity.All measurements showed no damage of the battery.The only damage was the visible deformation which according to the supplier was not the result of an overstressing of the battery.Furthermore, the integrated safety circuit functioned without any issue (overvoltage and overtemperature).The passed test inhouse also confirmed that safety circuits integrated in the pcba were not damaged.It is suspected that the heat development was due to the high operation time, but still in defined range.It is assumed that the required cushion was not used appropriately, and this led to the patient complaint.An analysis of battery issues in relation to overstressed batteries was done.There were no indications that show battery specific problems.In summary no hardware or software problem was found which would explain the reported burn of the patient.The manufacturer is not considering further actions resulting from this event as no systematic error has been recognized.

• Brand Name: MAGNETOM PRISMA
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; henkestrasse 127; erlangen, germany 91052 ; GM 91052
• MDR Report Key: 8635576
• MDR Text Key: 145910073
• Report Number: 3002808157-2019-77792
• 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,user f
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 04/11/2019

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: 10849582
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/11/2019
• Initial Date FDA Received: 05/23/2019
• Supplement Dates Manufacturer Received: 12/10/2019
• Supplement Dates FDA Received: 12/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 19 YR
• Patient Weight: 70