MalfunctionFLE
MIDMARK
Received Apr 6, 2026 · Event occurred Mar 12, 2026
Report 1523530-2026-00002 · MDR key 24788838
Device
Generic name
Midmark M11-020 Ultraclave
Manufacturer
Midmark CorporationModel number
M11-020Catalog number
M11-020
Lot number
N/A
Product problems
- Defective Component
Patient
NA · Unknown
- Tinnitus
Narrative
Description of Event or Problem
CLINICAL TRAINER REPORTED WHILE RUNNING A STERILIZATION CYCLE THE STERILIZER FELL OFF OF THE COUNTERTOP ONTO THE FLOOR. THE NOISE CREATED DURING THE INCIDENT LEFT A RINGING SOUND IN HER EARS.
Additional Manufacturer Narrative
WHILE RUNNING A STERILIZATION CYCLE THE UNIT FELL OFF THE COUNTERTOP. THE NOISE FROM THE EVENT CAUSED A RINGING SOUND IN THE CLINICIANS EARS. THE CLINICIAN WAS EVALUATED AND RETURNED TO WORK.