MalfunctionMSH
VERSAFLO
Received Oct 8, 2020 · Event occurred Sep 10, 2020
Report 10648398 · MDR key 10648398
Device
Product problems
- Break
- Loose or Intermittent Connection
- Material Puncture/Hole
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
PAPR HOOD HAS DEVELOPED HOLE- IT APPEARS STITCHING HAS COME LOOSE. SEVERAL OTHER AREAS NOTED AROUND ELASTIC WITH BROKEN THREADS.