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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SST GROUP, INC.; DEVICE, DIGITAL IMAGE STORAGE, RADIOLOGICAL
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SST GROUP, INC.; DEVICE, DIGITAL IMAGE STORAGE, RADIOLOGICAL Back to Search Results
Device Problem Output Problem (3005)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/16/2019
Event Type  malfunction  
Event Description
Disk burners do not work in a timely matter.Radiology was not given enough notification from the ed to get a disk made for the patient being transferred out to another hospital.There was down time for days, so no images could be pushed.While troubleshooting the disk burners, the patient left the hospital without any images.This could result in a patient needed to be re-imaged again at the next hospital and charged again for the same exams all because communication could not be given in a more appropriate amount of time.From the systems analyst: the issue is with the group policy that the hospital applies to the computer.It disconnects the burner drives from the computer when group policy is updated.Currently we have information technology and group policy staff working on a solution.We have "experimented" with several fixes without resolution.Sst group has been contacted.
 
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Type of Device
DEVICE, DIGITAL IMAGE STORAGE, RADIOLOGICAL
Manufacturer (Section D)
SST GROUP, INC.
309 laurelwood road suite 20
santa clara CA 95054
MDR Report Key9601275
MDR Text Key175415471
Report Number9601275
Device Sequence Number1
Product Code LMB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/31/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/31/2019
Event Location Hospital
Date Report to Manufacturer01/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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