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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE OEC MEDICAL SYSTEM, INC. MINI C-ARM; SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE INTENSIFIER

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GE OEC MEDICAL SYSTEM, INC. MINI C-ARM; SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE INTENSIFIER Back to Search Results
Model Number MINIVIEW 6800 HP
Device Problem Failure to Power Up (1476)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/20/2018
Event Type  malfunction  
Event Description
Mini c-arm screen would not turn on.
 
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Brand Name
MINI C-ARM
Type of Device
SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE INTENSIFIER
Manufacturer (Section D)
GE OEC MEDICAL SYSTEM, INC.
salt lake city UT 84116
MDR Report Key7938747
MDR Text Key123266185
Report NumberMW5080387
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 Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 10/03/2018
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 Health Professional
Device Model NumberMINIVIEW 6800 HP
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/04/2018
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age57 YR
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