FDA Adverse Event Malfunction Summary report: N

OBIX

MDR report key: 2453953 · Received January 30, 2012

Report

Report Number
2453953
Event Type
Malfunction
Date Received
January 30, 2012
Date of Event
November 6, 2011
Report Date
December 16, 2011
Manufacturer
CLINICAL COMPUTER SYSTEMS, INC.
Product Code
HGM
Product Problem
Yes
Report Source
User Facility report
Reporter Location
CA, US

Narratives

Description of Event or Problem · 1

DURING THE EARLY MORNING OF A RECENT NIGHT SHIFT, ALL OF THE OBIX BEDS WENT TO A "HOLD" CONDITION, RESULTING IN LOSS OF MONITORNIG FOR THE PATIENTS IN THE 27 BED UNIT. WHEN OBIX TECH SUPPORT WAS CALLED, WE WERE TOLD THAT THEIR TECHNICIAN WAS ON ANOTHER CALL AND TO CALL BACK IN 20MIN IF WE DID NOT HEAR FROM THEM. APPROXIMATELY 25 MINUTES LATER THE BEDS STARTED TO COME BACK ON LINE AND BY 30 MINUTES AFTER THE CALL, ALL BEDS AND CENTRAL MONITORING WAS BACK ON-LINE. OBIX ORIGINALLY ATTRIBUTED THIS FAILURE TO THEIR SYSTEM NOT BEING ABLE TO ACCEPT THE TIME CHANGE PUSH (CHANGE FROM DST TO STANDARD TIME). LATER WE WERE TOLD THIS IS NORMAL BUT SHOULD TAKE LESS THAN ONE MINUTE TO COMPLETE. WE THINK THIS IS ANOTHER DESIGN FLAW AND IS DEFINITELY SOMETHING THAT OBIX SHOULD HAVE CONSIDERED AT INSTALLATION.APPROXIMATELY 12 HOURS LATER ON THE SAME DATE, OBIX BEDS AGAIN WENT TO A BED HOLD STATUS. OBIX TECH SUPPORT WAS CALLED AND THEY ADVISED THAT ALL OF THE OBIX SERVICES HAD SHUT DOWN FOR UNKNOWN REASONS. OBIX STARTED THEM REMOTELY AND 30 MINUTES LATER THE SYSTEM WAS BACK ON LINE. THIS PROBLEM HAS YET TO BE EXPLAINED BY OBIX. IT HAS NOT OCCURRED SINCE.======================MANUFACTURER RESPONSE FOR PERINATAL DATA SYSTEM, OBIX (PER SITE REPORTER).======================SEE EVENT DESCRIPTION.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 OBIX PERINATAL DATA SYSTEM HGM CLINICAL COMPUTER SYSTEMS, INC. OBIX *

Patients

Seq Age Sex Outcome Treatment
1 * NO OTHER THERAPIES