DEXIS IMAGING SUITE

Report

• Report Number: 2530069-2015-00010
• Event Type: Malfunction
• Date Received: December 30, 2015
• Date of Event: December 3, 2015
• Report Date: December 3, 2015
• Manufacturer: IMAGING SCIENCES INTERNATIONAL / GENDEX / DEXIS
• Product Code: LLZ
• PMA / PMN Number: K090431
• Product Problem: Yes
• Report Source: Manufacturer report
• Reporter Location: CA
• Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

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.

Description of Event or Problem · 1

THE CUSTOMER REPORTED THAT INCORRECT PATIENT IS DISPLAYED WHEN CLICKING DIRECTLY ON A PATIENT NAME IN THE DEXIS (PATIENT) ADMINISTRATION SCREEN. NO INJURIES HAVE BEEN REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
860519	DEXIS IMAGING SUITE	PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM	LLZ	IMAGING SCIENCES INTERNATIONAL / GENDEX / DEXIS	DEXIS 10.1.2

Patients

Seq	Age	Sex	Outcome	Treatment
1

Terms

Patient problem · 1

• No Known Impact Or Consequence To Patient

Product problems · 1

• Patient Data Problem

Source type · 1

• USER FACILITY