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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC DISCOVERY CT750 HD; COMPUTED TOMOGRAPHY X-RAY SYSTEM
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GE MEDICAL SYSTEMS, LLC DISCOVERY CT750 HD; COMPUTED TOMOGRAPHY X-RAY SYSTEM Back to Search Results
Model Number CSPH05
Device Problem Unintended System Motion (1430)
Patient Problem Laceration(s) (1946)
Event Date 12/21/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4).Ge healthcare's investigation is ongoing.A follow up report will be submitted when the investigation has been completed.H3 other text : device evaluation anticipated, but not yet begun.
 
Event Description
It was reported that while servicing the device, an fe sustained a hand injury that was treated with surgery.
 
Manufacturer Narrative
During servicing of the axial drive, the fe heard sound coming from the drive belt side when rotating the gantry.He was investigating the source of the sound by checking the tension of the axial belt with his finger while rotating the gantry.His finger was pinched between the axial belt and the gear, and the nail of the index finger and upper portion was cut.The injury was treated with surgery.
 
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Brand Name
DISCOVERY CT750 HD
Type of Device
COMPUTED TOMOGRAPHY X-RAY SYSTEM
Manufacturer (Section D)
GE MEDICAL SYSTEMS, LLC
3000 n grandview blvd.
waukesha, WI 53188
MDR Report Key11194391
MDR Text Key227552479
Report Number2126677-2021-00023
Device Sequence Number1
Product Code JAK
Combination Product (y/n)N
PMA/PMN Number
K120833
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 03/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberCSPH05
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received03/01/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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