inforMED
MalfunctionLHC

HUSH SLUSH UNIT

Received Sep 22, 2020 · Event occurred Aug 28, 2020

Report 8043817-2020-00007 · MDR key 10570318

Device

Generic name

Surgical Slush Console

Model number

ORS-1075HS

Product problems

  • No Apparent Adverse Event
  • No Apparent Adverse Event

Patient

Not reported

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

Narrative

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS A SPARK FROM THE SLUSH UNIT DURING A CASE IN THE (B)(6) OPERATING ROOM. THERE ARE NO KNOWN ADVERSE EFFECTS TO THE PATIENT.