inforMED
MalfunctionMRI

MICROTEK

Received Jan 19, 2022 · Event occurred Nov 30, 2021

Report 8043817-2022-00002 · MDR key 13289798

Device

Generic name

Ems Immobile-vac Matteress

Model number

81-A5000

Catalog number

NA

Lot number

NOT PROVIDED

Product problems

  • Unintended Deflation
  • Unintended Deflation

Patient

Unknown

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

Narrative

Description of Event or Problem

IT WAS REPORTED THAT THE UNIT WAS NOT HOLDING AIR. NO PATIENT INJURY, INFECTION, OR COMPLICATIONS WERE REPORTED.