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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE HEALTHCARE IT PACS HW SERVER SYSTEM, IMAGE PROCESSING, RADIOLOGIC

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GE HEALTHCARE IT PACS HW SERVER SYSTEM, IMAGE PROCESSING, RADIOLOGIC Back to Search Results
Model Number IAS001
Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
Patient Problems Death (1802); Pain (1994); Obstruction/Occlusion (2422)
Event Date 05/21/2016
Event Type  Death  
Manufacturer Narrative
Patient information could not be obtained due to country privacy laws. The initial reporter is located outside the u. S. , and therefore this information is not provided due to country privacy laws. Manufacture date is unknown. 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 the patient was hospitalized for a small bowel obstruction and pain. A ct was ordered for the patient. The ct scan was performed on (b)(6) 2016. This study was viewed by radiologist on (b)(6) 2016 when an exam note was performed by the radiologist that indicated: sbo with free air and fluid. The ward doctor was notified of these findings on (b)(6) 2016. The ward doctor determined that the patient was too frail for surgery, so no surgery was performed. The patient died on (b)(6) 2016. The final report (signed (b)(6) 2016) indicated that there was a delay in reading because the study was incorrectly date and time stamped.
 
Manufacturer Narrative
The investigation revealed that the merging of two patient studies was performed correctly and that the study had the appropriate time and date stamp after the merge. The investigation also revealed that the exam was present on the worklist and available for use by the radiologist. The investigation did not identify any deficiency with the cpacs product. The cpacs product is working as designed.
 
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Brand NamePACS HW SERVER
Type of DeviceSYSTEM, IMAGE PROCESSING, RADIOLOGIC
Manufacturer (Section D)
GE HEALTHCARE IT
540 w. northwest hwy
barrington IL 60010
Manufacturer (Section G)
GE HEALTHCARE IT
540 w. northwest hwy
barrington IL 60010
Manufacturer Contact
deb lahr
540 w. northwest hwy.
barrington, IL 60010
MDR Report Key5735992
MDR Text Key47752290
Report Number3004526608-2016-00001
Device Sequence Number1
Product Code LLZ
Combination Product (y/n)N
PMA/PMN Number
K043415
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 07/27/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/20/2016
Is this an Adverse Event Report? Yes
Device Operator
Device Model NumberIAS001
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/25/2016
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

Patient Treatment Data
Date Received: 06/20/2016 Patient Sequence Number: 1
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