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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. INGENUITY CT; COMPUTED TOMOGRAPHY SYSTEM
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PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. INGENUITY CT; COMPUTED TOMOGRAPHY SYSTEM Back to Search Results
Model Number 728326
Device Problems Signal Artifact/Noise (1036); Incorrect Or Inadequate Test Results (2456)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
The customer reported that during a brain procedures, the image quality is not as desired and the images exhibit artifacts, the philips clinical specialist confirmed that no misinterpretation has occurred and no rescan was necessary.There was no harm to a pt, operator or bystander.The customer reported several issues with the image quality, including artifacts appearing like subdural hematomas.
 
Manufacturer Narrative
(b)(4).We will file a follow up mdr at the completion of the investigation.(b)(4).
 
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Brand Name
INGENUITY CT
Type of Device
COMPUTED TOMOGRAPHY SYSTEM
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
595 miner rd.
cleveland OH 44143
Manufacturer Contact
kumudini carter
595 miner rd.
cleveland, OH 44143
4404833032
MDR Report Key4373607
MDR Text Key5116378
Report Number1525965-2014-00213
Device Sequence Number1
Product Code JAK
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K033326
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/27/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number728326
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/27/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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