InjuryMSH

LAMDOWN KN95

Received Apr 30, 2020 · Event occurred Apr 29, 2020

Report MW5094338 · MDR key 10017055

Device

Generic name

Respirator, Surgical

Manufacturer

Lanshan Shendun Technology Co., Ltd.

Catalog number

SD-KN95

Product problems

Device Emits Odor
Incorrect, Inadequate or Imprecise Result or Readings
Fitting Problem

Patient

Not reported

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

Narrative

Description of Event or Problem

RECEIVED KN95 MASKS WHICH FIT TESTS WITH THE PORTACOUNT WAS UTILIZED; 0 OF 12 PASSED WITH A MEDIAN FIT FACTOR OF 20.75 (HIGHEST FIT FACTOR RECORDED WAS 68). ALSO MULTIPLE TESTS WERE DONE UTILIZING THE USER INSTRUCTIONS ON HOW TO CONFIGURE THE STRAPS. TESTINGS FAILED. STAFF ALSO SAID THEY SMELLED LIKE BURNING TIRES. FDA SAFETY REPORT #(B)(4).