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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. INGENUITY CORE; SYSTEM X-RAY, TOMOGRAPHY, COMPUTED
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PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. INGENUITY CORE; SYSTEM X-RAY, TOMOGRAPHY, COMPUTED Back to Search Results
Model Number 728321
Device Problems Signal Artifact/Noise (1036); Incorrect Or Inadequate Test Results (2456)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  No Answer Provided  
Event Description
While philips senior product manager was attending the (b)(4) a radiologist mentioned to him that intermittently there were instances where there were image quality artifacts in brain images which may result in false positive findings of ct subarachnoid hemorrhage, when read by residents.Patients were followed-up on mri to confirm diagnosis and provided the appropriate treatment.The radiologist did confirm there was no patient harm.
 
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 CORE
Type of Device
SYSTEM X-RAY, TOMOGRAPHY, COMPUTED
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 Key4373638
MDR Text Key5260505
Report Number1525965-2014-00217
Device Sequence Number1
Product Code JAK
Combination Product (y/n)N
Reporter Country CodeUS
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 12/04/2014
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 Number728321
Device Catalogue NumberIII
Device Lot NumberV4.0
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/04/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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