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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC; SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
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SIEMENS MEDICAL SOLUTIONS USA, INC; SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED Back to Search Results
Model Number 10281299
Device Problems Overheating of Device (1437); Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/01/2016
Event Type  malfunction  
Event Description
Patient was taken to cath lab for gastroduodenal artery (gda) embolization.The patient was prepped and intubated.As the md was about to begin the procedure, the fluoro equipment began alarming.Message displayed: "hot tube".The patient was transported to another cath lab room for the procedure.It was determined the cooling mechanism for the c-arm ran out of water to cool the tube causing it to overheat.It was repaired and remains in service.
 
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Type of Device
SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
Manufacturer (Section D)
SIEMENS MEDICAL SOLUTIONS USA, INC
810 innovation dr.
knoxville TN 37932
MDR Report Key6124551
MDR Text Key60787473
Report Number6124551
Device Sequence Number1
Product Code JAA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 10/04/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Unknown
Device Model Number10281299
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/04/2016
Device Age4 YR
Event Location Hospital
Date Report to Manufacturer10/04/2016
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/23/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
OTHER, UNKNOWN; YES BUT THEY ARE NOT KNOWN
Patient Age77 YR
Patient Weight58
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