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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 Problem Detachment of Device or Device Component (2907)
Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Event Date 05/10/2019
Event Type  malfunction  
Manufacturer Narrative
A ge healthcare investigation has been initiated and is currently ongoing. A follow-up summary report will be submitted upon completion of the investigation.
 
Event Description
This report summarizes 1 malfunction events. On (b)(6) 2019, the radiographic technologist at (b)(6) hospital in the united states reported that as they were rotating the proteus system collimator with model number 2259973-3 for positioning during a patient exam, the collimator detached from the tube support. As the collimator detached, it detached in the technologists hands who then prevented the collimator from falling. The collimator did not impact a patient and there was no injury related to this event.
 
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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 Contact
steven walczak
3000 north grandview boulevard
waukesha, WI 
MDR Report Key8837881
MDR Text Key216604022
Report Number9613445-2019-00006
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)Y
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/15/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/29/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
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
Event Location No Information
Date Manufacturer Received08/12/2019
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

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