FDA Adverse Event Malfunction Summary report: N

PICOM

MDR report key: 691486 · Received March 6, 2006

Report

Report Number
691486
Event Type
Malfunction
Date Received
March 6, 2006
Date of Event
March 3, 2006
Report Date
March 6, 2006
Manufacturer
SCIMAGE INC.
Product Code
LLZ
Product Problem
Yes
Report Source
User Facility report
Reporter Location
OH, US

Narratives

Description of Event or Problem · 1

PATIENT HAD CARDIAC CATHETERIZATION DONE IN THE EARLY MORNING HOURS. LATER IN THE DAY THE CARDIOLOGIST ATTEMPTED TO VIEW THE CARDIAC IMAGES, BUT THEY WERE NOT ON THE PICOM SYSTEM. PHYSICIAN LOOKED ON THE GATEWAY COMPUTER AND THE IMAGES WERE THERE. IT WAS DISCOVERED THAT THESE IMAGES WERE SAVED ON THE GATEWAY HARD DRIVE AND HAD NEVER TRANSFERRED TO THE PICOM SERVER AS THEY ARE SUPPOSED TO. THE GATEWAY COMPUTER WAS REFRESHED AND THE IMAGES WERE MANUALLY TRANSFERRED TO THE PICOM SERVER. SCIMAGE THE VENDOR WAS CONTACTED AND WERE ABLE TO DETECT FROM THEIR REMOTE LOCATION THAT THE IMAGES DID NOT TRANSFER FROM THE GATEWAY COMPUTER TO PICOM BUT WERE UNABLE TO EXPLAIN WHY. POTENTIAL EXISTED FOR PATIENT TO HAVE TO HAVE CARDIAC CATH REDONE IF IMAGES HAD BEEN LOST.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 PICOM DIGITAL IMAGING SYSTEMS, PORTAL LLZ SCIMAGE INC. * *

Patients

Seq Age Sex Outcome Treatment
1 39 YR