MalfunctionMSH

VERSAFLO

Received Sep 4, 2020 · Event occurred Aug 19, 2020

Report 10493629 · MDR key 10493629

Device

Generic name

Respirator,surgical

Manufacturer

3m Company

Model number

TR-601N

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

CLEANING PROCESS WAS NOT THE CURRENT PROCESS FROM 3M BECAUSE THEY HAD NOT PROVIDED IT TO US. THE CHEMICALS CAUSED THE PAPR (POWERED AIR PURIFYING RESPIRATOR) UNIT TO BREAK APART.