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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE HANGWEI MEDICAL SYSTEMS CO., LTD. PROTEUS XR/A RADIOGRAPHIC SYSTEM SYSTEM, X-RAY, STATIONARY

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GE HANGWEI MEDICAL SYSTEMS CO., LTD. PROTEUS XR/A RADIOGRAPHIC SYSTEM SYSTEM, X-RAY, STATIONARY Back to Search Results
Model Number 2259973-3
Device Problems Detachment of Device or Device Component (2907); Device Fell (4014)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/24/2021
Event Type  malfunction  
Event Description
On (b)(6) 2021, the customer at (b)(6) er in (b)(6) usa reported that as they were positioning the collimator during system setup using their proteus fixed radiographic system, the collimator detached from the tube. When the collimator detached, it was held up by the collimator cabling and therefore was prevented from falling. There was no injury related to this event.
 
Manufacturer Narrative
Ge healthcare 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.
 
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Brand NamePROTEUS XR/A RADIOGRAPHIC SYSTEM
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 (Section G)
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, WI 53118-1696
MDR Report Key12728698
MDR Text Key281012668
Report Number9613445-2021-00005
Device Sequence Number1
Product Code KPR
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K993090
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/16/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2259973-3
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received12/15/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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