FDA Adverse Event Death Summary report: N

ISITE PACS

MDR report key: 1057877 · Received June 9, 2008

Report

Report Number
2954704-2008-00003
Event Type
Death
Date Received
June 9, 2008
Report Date
June 9, 2008
Manufacturer
PHILIPS HEALTHCARE INFORMATICS, INC.
Product Code
LLZ
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
WA, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

WE RECEIVED NOTIFICATION FROM A USER FACILITY THAT A DELAY IN READING IMAGES MAY HAVE CONTRIBUTED TO A PT DEATH. OUR DEVICE, ISITE PACS DID NOT MALFUNCTION, HOWEVER, WHEN THE USER FACILITY ATTEMPTED TO SEND THE IMAGES TO ANOTHER SITE VIA ISITE PACS FOR RADIOLOGIST READING AND DIAGNOSIS, THERE WAS AN EXTREME DELAY DUE TO LATENCY IN THEIR NETWORK. IT WAS REPORTED TO US THAT A PT DIED WHILE WAITING FOR THE IMAGE TO TRANSFER AND BE READ REMOTELY, HOWEVER, THE USER FACILITY HAS NOT PROVIDED FURTHER DETAIL SUCH AS DATE OR CAUSE OF DEATH TO ENABLE US TO INVESTIGATE IF THE USER FACILITIES NETWORK CONNECTION TO ISITE PACS MAY HAVE CONTRIBUTED TO THE REPORTED DEATH. WE HAVE MADE REPEATED ATTEMPTS TO CONFIRM DEATH, DATE OF EVENT AND CONTRIBUTING FACTOR, AND WILL CONTINUE TO DO SO. WE WILL FOLLOW-UP ON THIS REPORT ONCE ADD'L' INFO IS RECEIVED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 ISITE PACS PICTURE ARCHIVING & COMMUNICATION SYSTEM LLZ PHILIPS HEALTHCARE INFORMATICS, INC.

Patients

Seq Age Sex Outcome Treatment
1 Death