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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEXIS DEXIS IMAGING SUITE PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM

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DEXIS DEXIS IMAGING SUITE PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM Back to Search Results
Model Number 1.008.7932
Device Problem Computer Software Problem (1112)
Patient Problem No Patient Involvement (2645)
Event Date 05/17/2018
Event Type  malfunction  
Manufacturer Narrative
The investigation revealed that the customer used the software in a multi-workstation environment, which is a scenario not indicated in the dexis user manual. This reported issue is only observed when multiple instances of dexis (patient) administration are active, which is not considered to be a normal scenario for the use of dexis. The issue can be resolved by reloading the patient list in the active dexis administration window. The user is able to determine the correct patient image and no injuries have been reported. This concludes the investigation.
 
Event Description
It was reported that a different patient profile will launch when selecting a patient in the dexis imaging suite patient selection window. The customer reported that the incorrect patient is displayed when clicking directly on a patient's name in dexis administration screen. No injuries were reported. There was no impact to patient care.
 
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Brand NameDEXIS IMAGING SUITE
Type of DevicePICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
Manufacturer (Section D)
DEXIS
1910 north penn road
hatfield PA 19440
Manufacturer (Section G)
IMAGING SCIENCES INTERNATIONAL/GENDEX/DEXIS
2800 crystal drive
hatfield PA 19440
Manufacturer Contact
christie samsa
2800 crystal drive
hatfield, PA 19440
2679540285
MDR Report Key7538126
MDR Text Key109111013
Report Number2530069-2018-00003
Device Sequence Number1
Product Code LLZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K090431
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Service and Testing Personnel
Type of Report Initial
Report Date 05/23/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/23/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Dentist
Device Model Number1.008.7932
Device Catalogue Number1.008.7932
Device Lot Number10.1.2
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/17/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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