inforMED
LMD

OR INTEGRATION MONITOR

Received Oct 31, 2014 · Event occurred Oct 2, 2014

Report 1000404456-2014-00010 · MDR key 4218017

Device

Generic name

Integration Monitor

Product problems

  • No Display/Image

Patient

Not reported

  • No Known Impact Or Consequence To Patient

Narrative

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE AND SWAPPED CABLING FROM ANOTHER MONITOR IN THE ROOM WITH THE MONITOR SUBJECT OF THE REPORTED EVENT AND THE ISSUE WAS NOT RESOLVED. THE MONITOR SUBJECT OF THE REPORTED EVENT WAS RETURNED TO STERIS FOR EVALUATION. EVALUATION OF THE MONITOR DETERMINED THAT THE DRIVER BOARD REQUIRED REPLACEMENT. THE DRIVER BOARD WAS REPLACED AND THE MONITOR WAS CONFIRMED TO BE OPERATIONAL.

Description of Event or Problem

THE USER FACILITY REPORTED THAT THEIR OR MONITOR IS GOING BLANK DURING PATIENT PROCEDURES. NO INJURIES OR PROCEDURAL DELAYS OR CANCELLATIONS WERE REPORTED.