inforMED
MalfunctionMSH

RESPIRATOR,SURGICAL

Received Dec 16, 2021 · Event occurred Nov 16, 2021

Report 13017652 · MDR key 13017652

Device

Generic name

Respirator,surgical

Model number

PFR95-170

Product problems

  • Break
  • Melted

Patient

Unknown

  • Insufficient Information
  • Insufficient Information

Narrative

Description of Event or Problem

RN ATTEMPTED TO PUT ON MULTIPLE MASKS AND FOUND THAT THE STRAPS ON EACH MASK WERE MELTED TOGETHER. ALSO, WHEN STRAPS WERE PULLED TO PUT AROUND HEAD, THE STRAPS SNAPPED APART.