inforMED
MalfunctionKPY

HARMONY RSHIELD RADIATION PROTECTION DEVICE

Received Feb 16, 2022 · Event occurred Jan 21, 2022

Report 1043572-2022-00014 · MDR key 13545704

Device

Generic name

Shield

Product problems

  • Loose or Intermittent Connection
  • Loose or Intermittent Connection

Patient

Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

THE USER FACILITY REPORTED THAT A DOCTOR ATTEMPTED TO MOVE THE HARMONY RSHIELD RADIATION PROTECTION DEVICE ATTACHED TO THEIR HARMONY LED SURGICAL LIGHTING SYSTEM, THE SHIELD SUBSEQUENTLY DETACHED FROM THE LIGHTING SYSTEM. THE EMPLOYEE CAUGHT THE SHIELD AS IT DETACHED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF INJURY.

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ON SITE TO INSPECT THE LIGHTING SYSTEM AND CONFIRMED THE SHIELD HAD DETACHED. STERIS HAS PROVIDED THE USER FACILITY WITH A QUOTE TO REPLACE THE HARMONY RSHIELD RADIATION PROTECTION DEVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.