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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS SHENZHEN MAGNETIC RESONANCE LTD. MAGNETOM SPECTRA SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

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SIEMENS SHENZHEN MAGNETIC RESONANCE LTD. MAGNETOM SPECTRA SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING Back to Search Results
Model Number 10655588
Device Problem Excessive Heating (4030)
Patient Problem Unspecified Tissue Injury (4559)
Event Date 12/09/2020
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 examination on the magnetom spectra system. While undergoing an examination with the body 12 coil, a female patient reported an area of redness on the left thigh. The patient was treated with silver sulfadiazine and the redness disappeared after a few days. We are unaware of any further impact to the state of health of the patient involved. Siemens has requested additional information in order to conduct an investigation of the reported event.
 
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Brand NameMAGNETOM SPECTRA
Type of DeviceSYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
Manufacturer (Section D)
SIEMENS SHENZHEN MAGNETIC RESONANCE LTD.
gaoxin c ave.
2nd, hi-tech industrial park
shenzhen, china 51805 7
CH 518057
Manufacturer (Section G)
SIEMENS SHENZHEN MAGNETIC RESONANCE LTD.
siemens mri center, gaoxin c.
hi-tech industrial park
shenzhen, china 51805 7
CH 518057
Manufacturer Contact
meredith adams
40 liberty blvd.
65-1a
malvern, PA 19355
6104486461
MDR Report Key11038420
MDR Text Key222365149
Report Number3004754211-2020-59329
Device Sequence Number1
Product Code LNH
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K153447
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Remedial Action Repair
Type of Report Initial,Followup
Report Date 12/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number10655588
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/02/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 12/18/2020 Patient Sequence Number: 1
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