InjuryMSH
BEI BEI KN95
Received Apr 30, 2020 · Event occurred Apr 29, 2020
Report MW5094334 · MDR key 10017029
Device
Product problems
- Device Emits Odor
- Incorrect, Inadequate or Imprecise Result or Readings
- Inadequacy of Device Shape and/or Size
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 USING THE PORTACOUNT WAS UTILIZED; 0 OF 10 PASSED WITH A MEDIAN FIT FACTOR OF 14.8 (HIGHEST FIT FACTOR RECORDED WAS 23). ALSO MULTIPLE TESTS ON THE KN95 FOLLOWING THE USER INSTRUCTIONS ON HOW TO CONFIGURE THE STRAPS WERE ATTEMPTED, WHICH ALSO FAILED. STAFF FELT THEY SMELLED LIKE BURNING TIRES. FDA SAFETY REPORT ID# (B)(4).