inforMED
MalfunctionLMD

HV1000

Received Jun 15, 2026 · Event occurred Mar 9, 2025

Report 3008776287-2026-00414 · MDR key 25510229

Device

Generic name

Integration System

Model number

HV1000

Catalog number

XEH1BASE

Lot number

(10)3.0.0

Product problems

  • Display or Visual Feedback Problem

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT TO INSPECT THE HV1000 INTEGRATION SYSTEM AND FOUND THAT THE TOUCH PANEL REQUIRED TIGHTENING. THE TECHNICIAN TIGHTENED THE TOUCH PANEL, TESTED THE FUNCTION AND OPERATION OF THE UNIT, CONFIRMED IT TO BE OPERATING TO SPECIFICATION, AND RETURNED THE UNIT TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Description of Event or Problem

THE USER FACILITY REPORTED THAT THE CONTROL BOX CONNECTED TO THEIR HV1000 INTEGRATION SYSTEM WAS UNRESPONSIVE. NO REPORT OF INJURY.