• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SAMSUNG ELECTRONICS CO, LTD GC85A DIGITAL DIAGNOSTIC X-RAY SYSTEM,

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SAMSUNG ELECTRONICS CO, LTD GC85A DIGITAL DIAGNOSTIC X-RAY SYSTEM, Back to Search Results
Model Number GC85A
Device Problem Unintended System Motion (1430)
Patient Problem Limb Fracture (4518)
Event Date 10/21/2021
Event Type  malfunction  
Event Description
The customer reported that while setting up a patient for a scan, the test sensors on the safety arm of the device were not enabled. The movement of the device continued onto the patient's foot. No further information on patient injury was received at the time of the initial complaint.
 
Manufacturer Narrative
After review by neurologica's field service representative, it was stated that the safety sensor of the device did not go on and the device movement continued, and as a result came down to patients foot. It was clarified that after the patient was examined, no injury resulted from this incident. The field service representative determined that one of the sensor settings was not on, which caused the device's movement. The sensors were enabled and tested and found to be working appropriately. The customer stated that they will be filing an incident report and the above narrative adds context to the report submitted by the hospital. There was no user harm (patient or operator), and this incident is estimated to happen due to a user-induced issue. Future service calls will be monitored to ensure there is no trend in similar incidents.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameGC85A
Type of DeviceDIGITAL DIAGNOSTIC X-RAY SYSTEM,
Manufacturer (Section D)
SAMSUNG ELECTRONICS CO, LTD
129, samsung-ro, yeongtong-gu
suwon-si, gyeonggido 16677
KS 16677
Manufacturer (Section G)
SAMSUNG ELECTRONICS CO., LTD.
129, samsung-ro yeongtong-gu
suwon-si, gyeonggido 16677
KS 16677
Manufacturer Contact
jeongwoo kim
129, samsung-ro yeongtong-gu
suwon-si, gyeonggido 16677
KS   16677
MDR Report Key12981880
MDR Text Key285471953
Report Number3010300212-2021-00008
Device Sequence Number1
Product Code KPR
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K181629
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/13/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberGC85A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/17/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/21/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No

-
-