inforMED

OR INTEGRATION MONITOR

Received Apr 10, 2015 · Event occurred Mar 17, 2015

Report 1000404456-2015-00004 · MDR key 4681889

Device

Generic name

Monitor

Product problems

  • Unintended Collision
  • Human-Device Interface Problem

Patient

Not reported

  • Head Injury

Narrative

Additional Manufacturer Narrative

STERIS PROVIDED THE USER FACILITY WITH INFORMATION REGARDING A MONITOR BUMPER GUARD. NO BUMPER GUARD WAS PRESENT ON THE MONITOR PRIOR TO THE REPORTED EVENT. THE MONITOR BUMPER GUARD IS AN OPTIONAL PIECE SOLD SEPARATELY FROM THE OR INTEGRATION MONITOR. THE EMPLOYEE HAS RETURNED TO NORMAL WORK DUTIES.

Description of Event or Problem

THE USER FACILITY REPORTED AN EMPLOYEE HIT HIS HEAD ON AN INFIELD MONITOR DUE TO INATTENTIVENESS. THE EMPLOYEE SUBJECT OF THE REPORTED EVENT SOUGHT AND WAS ADMINISTERED MEDICAL TREATMENT. NO REPORT OF PROCEDURAL DELAY OR CANCELLATION.