inforMED
MalfunctionMSH

TR-600 VERSAFLO

Received May 4, 2020 · Event occurred Mar 10, 2020

Report 10020246 · MDR key 10020246

Device

Generic name

Respirator,surgical

Manufacturer

3m Company

Model number

TR-6710N

Lot number

6710U1118B21-0

Product problems

  • Break

Patient

Not reported

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

DURING EDUCATION SOMEONE ATTEMPTED TO MANIPULATE THE PLASTIC TAB WHICH LOCKS THE FILTER TO COVER THE DEVICE AND SUBSEQUENTLY BROKE IT RENDERING THE PAPR UNUSABLE UNTIL A REPLACEMENT FILTER CAN BE OBTAINED.