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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE HANGWEI MEDICAL SYSTEMS CO., LTD. BRIGHTSPEED; COMPUTED TOMOGRAPHY X-RAY SYSTEM
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GE HANGWEI MEDICAL SYSTEMS CO., LTD. BRIGHTSPEED; COMPUTED TOMOGRAPHY X-RAY SYSTEM Back to Search Results
Model Number CSPD10
Device Problems Mechanical Jam (2983); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Laceration(s) (1946)
Event Date 12/03/2020
Event Type  Injury  
Manufacturer Narrative
Udi not required.Legal manufacturer: (b)(4).Ge healthcare's investigation is ongoing.A follow up report will be submitted when the investigation has been completed.
 
Event Description
It was reported that, while servicing the device, a field engineer sustained a hand injury that was treated with stitches.
 
Manufacturer Narrative
During maintenance of the system, the fe turned off all the equipment.After completing it, he powered the system back on but the table didn't communicate with the rest of the equipment.He disassembled the entire table for diagnosis and found that the cradle motor assembly did not move the roller.When forcing the roller with the hand, it rotated and injured his thumb.
 
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Brand Name
BRIGHTSPEED
Type of Device
COMPUTED TOMOGRAPHY X-RAY SYSTEM
Manufacturer (Section D)
GE HANGWEI MEDICAL SYSTEMS CO., LTD.
bld 3 1 yongchang north road
beijing economic and tech
beijing 10017 6
CH  100176
MDR Report Key11102109
MDR Text Key224591693
Report Number9613445-2020-00007
Device Sequence Number1
Product Code JAK
Combination Product (y/n)N
PMA/PMN Number
K052855
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 02/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/31/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberCSPD10
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received02/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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