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U.S. Department of Health and Human Services

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

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DEXIS, LLC DEXIS IMAGING SUITE PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM Back to Search Results
Model Number DEXIS 10.1.2
Device Problem Device Displays Incorrect Message (2591)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/31/2015
Event Type  malfunction  
Manufacturer Narrative
The customer used a scenario which was not indicated in the dexis user manual. A software evaluation was performed on dexis 10. 1. 2. Evaluation revealed that the 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 our investigation.
 
Event Description
The customer reported that the incorrect patient is displayed when clicking directly on a patient name in the dexis (patient) administration screen. No injuries have been reported.
 
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Brand NameDEXIS IMAGING SUITE
Type of DevicePICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
Manufacturer (Section D)
DEXIS, LLC
1910 north penn road
hatfield PA 19440
Manufacturer (Section G)
DEXIS, LLC
1910 north penn road
hatfield PA 19440
Manufacturer Contact
martin rajchel
2800 crystal drive
hatfield, PA 19440
2679540338
MDR Report Key5399938
MDR Text Key37723250
Report Number2530069-2016-00001
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 user facility
Reporter Occupation Dental Assistant
Type of Report Initial
Report Date 12/31/2015
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/29/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberDEXIS 10.1.2
Device Catalogue Number1.008.7932
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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