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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE HEALTHCARE UNIVERSAL VIEWER

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GE HEALTHCARE UNIVERSAL VIEWER Back to Search Results
Device Problems Adverse Event Without Identified Device or Use Problem; Insufficient Information
Event Date 03/14/2019
Event Type  Injury  
Manufacturer Narrative

(b)(4). Legal manufacturer: hcit (b)(4) - (b)(4). Initial reporter: (b)(6). Ge healthcare's investigation is ongoing. A follow-up report will be submitted when the investigation is complete. Device evaluation anticipated, but not yet begun.

 
Event Description

The customer reported cancer was not detected in a timely manner due to not viewing the additional series that was obtained. An mri study of the left knee was performed on (b)(6) 2019. It was ordered stat. The full study, containing 9 series was sent into the sites cpacs system within 30 minutes of acquisition. Using universal viewer, the radiologist opened the study on (b)(6) where a lesion in the distal femur shaft was identified. Dedicated radiology of femur was recommended. In (b)(6) of 2019, the radiologist who read the report identified need for more urgent follow up imaging after a re-review of mri knee study. It was identified that the 9th series had not been viewed on (b)(6). Further testing was performed on (b)(6), where a pet scan was done to classify the lesion as cancerous.

 
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Brand NameUNIVERSAL VIEWER
Type of DeviceUNIVERSAL VIEWER
Manufacturer (Section D)
GE HEALTHCARE
500 west monroe
chicago IL 60661
Manufacturer Contact
michele marousek
500 west monroe
MDR Report Key9123497
Report Number3004526608-2019-00001
Device Sequence Number1
Product CodeLLZ
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/15/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/26/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/05/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/01/1970
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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