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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE HANGWEI MEDICAL SYSTEMS CO., LTD. OPTIMA XR646 SYSTEM, X-RAY, STATIONARY

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GE HANGWEI MEDICAL SYSTEMS CO., LTD. OPTIMA XR646 SYSTEM, X-RAY, STATIONARY Back to Search Results
Device Problems Use of Device Problem (1670); Unintended Movement (3026)
Patient Problems Crushing Injury (1797); Injury (2348)
Event Date 01/15/2021
Event Type  Injury  
Manufacturer Narrative
Ge healthcare¿¿s investigation into the reported event has been initiated and is ongoing. A follow-up report will be submitted when the investigation has been completed. Device evaluation anticipated, but not yet begun.
 
Event Description
On (b)(6) 2021, during the installation of an optima xr646 fixed radiographic x-ray system at the (b)(6) hospital in (b)(6), the ge field service engineer (fe) reported they were injured while performing wall stand alignment calibrations. The fe stated they had placed their right hand on the wall stand column and their left hand was used to move the wall stand down toward the floor. The wall stand column covers were removed at the time of this event. As the wall stand moved down, the counterweight in the column moved up and pinched their finger between a section of the column and the counterweight resulting in a crushing injury to the fingertip that was treated with sutures. This is considered a serious injury.
 
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Brand NameOPTIMA XR646
Type of DeviceSYSTEM, X-RAY, STATIONARY
Manufacturer (Section D)
GE HANGWEI MEDICAL SYSTEMS CO., LTD.
west area of building no.3,
no.1 yongchang north road
beijing 10017 6
CH 100176
Manufacturer Contact
steven walczak
3000 north grandview boulevard
waukesha 
MDR Report Key11214569
MDR Text Key228189051
Report Number9613445-2021-00001
Device Sequence Number1
Product Code KPR
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K143270
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/22/2021
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? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/05/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2021
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: 01/22/2021 Patient Sequence Number: 1
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