FDA Adverse Event Malfunction Summary report: N

HORIZON CARDIOLOGY

MDR report key: 3304807 · Received July 19, 2013

Report

Report Number
3304807
Event Type
Malfunction
Date Received
July 19, 2013
Date of Event
June 11, 2013
Report Date
July 19, 2013
Manufacturer
MCKESSON TECHNOLOGIES INC.
Product Code
DQK
Product Problem
Yes
Report Source
User Facility report
Reporter Location
FL, US

Narratives

Description of Event or Problem · 1

DURING THE PREPARATION FOR AN ELECTIVE HEART PROCEDURE A RAID DRIVE ERROR MESSAGE CAME UP ON THE HORIZON CARDIOLOGY SYSTEM. I SPOKE TO OUR INFORMATION SYSTEMS (IS) DEPARTMENT ABOUT THE ERROR WHO INDICATED IT SHOULD BE A LOCAL DRIVE ISSUE. THE PATIENT WAS MOVED TO LAB 1 AND WE RECEIVED THE SAME ERROR. AT THE SAME TIME, THE TEAM IN LAB 3 RECEIVED THE ERROR. WHILE SPEAKING TO IS DEPARTMENT ABOUT THE PROBLEM A ST-ELEVATION MYOCARDIAL INFARCTION (STEMI) CASE WAS CALLED FOR THE PATIENT. PREPARATIONS ARE BEING MADE CURRENTLY TO DO THE CASE UTILIZING AN HP PORTABLE MONITOR. ALL ELECTIVE CASES ARE CURRENTLY ON HOLD.UPDATE: (B)(6) WAS ABLE TO FORCE ALL LABS INTO LOCAL MODE. DUE TO A DELAY IN THE STEMI PATIENT COMING TO THE DEPARTMENT (PATIENT WAS BEING STABILIZED) WE WERE ABLE TO GET THE STEMI LAB INTO LOCAL MODE AND DID NOT NEED TO PERFORM THE CASE UTILIZING THE PORTABLE MONITOR. WE WERE LATER NOTIFIED THAT THE SEQUEL DATABASE WAS BACK UP. THE ISSUE AROSE BECAUSE WHEN THE SEQUEL DATABASE FAILED IT DID NOT AUTOMATICALLY ROLL OVER TO THE REDUNDANT SERVER AS IT IS SUPPOSED TO. SYSTEMS ADMINISTRATOR IS MEETING WITH (B)(6) AND OUR HOSPITAL TEAM TO IDENTIFY WHY THIS DID NOT WORK AS DESIGNED. WHILE THERE WERE DELAYS IN THE CASES.LABS HAVE ALL BEEN REBOOTED AND ARE CURRENTLY FUNCTIONING PROPERLY.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
339680 HORIZON CARDIOLOGY COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK MCKESSON TECHNOLOGIES INC. * *

Patients

Seq Age Sex Outcome Treatment
1 62 YR