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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE HEALTHCARE C-PACS RA 1000

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GE HEALTHCARE C-PACS RA 1000 Back to Search Results
Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Insufficient Information (3190)
Patient Problem Misdiagnosis (2159)
Event Date 09/18/2018
Event Type  Injury  
Manufacturer Narrative
Udi not required. Weight could not be obtained. 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 a delay in surgery (x 8 days) following a missed fracture. Patient required hospitalization (unknown time) post surgery. The patient presented in the er on (b)(6) 2018 with acute trauma. An xr ankle right complete was ordered by emergency room clinician. Three views were obtained on a long cassette, providing anatomy beyond ankle to include mid shaft calf. These views were submitted for interpretation on the ra 1000 after they were magnified by the technologist and manually saved. The radiologist received the exam in the most recent saved state (magnified) and provided report based on this presentation. The radiologist had the option to view images as acquired at all times. The findings identified no radiographic evidence of acute displaced "ossious" fracture or dislocation involving the right ankle. The patient sought repeated care on (b)(6) 2018, with a history of right lower leg pain. As a result, the clinician ordered a xr leg right lower tibia/fibula exam. Four views were obtained. These views were submitted for interpretation on the ra 1000, revealing "a transverse fracture through the tibial shaft. " the initial images from (b)(6) 2018 were re-assessed on (b)(6) "2017" and addended as follows: "at the time of initial interpretation, the images were submitted in a magnified state that obscured visualization of the mid shaft tibial fracture. Upon reprocessing images, there is a nondisplaced midshaft tibial fracture apparent on these views. " the patient required surgery on (b)(6) 2018 for rod placement to repair a right nondisplaced tibial shaft fracture. Post surgery findings: there has been open reduction and internal fixation of the tibial diaphysis fracture with no evidence of complication status post surgery.
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Brand NameC-PACS
Type of DeviceRA 1000
Manufacturer (Section D)
500 west monroe
chicago IL 60661
Manufacturer Contact
michele marousek
500 west monroe
chicago, IL 
MDR Report Key8005893
MDR Text Key125024075
Report Number3004526608-2018-00001
Device Sequence Number1
Product Code LLZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/25/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received03/12/2019
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

Patient Treatment Data
Date Received: 10/25/2018 Patient Sequence Number: 1