inforMED
MalfunctionMNR

WATCH PAT ONE

Received Mar 16, 2026 · Event occurred Mar 7, 2026

Report MW5185242 · MDR key 24604672

Device

Generic name

Ventilatory Effort Recorder

Model number

AC2110800

Patient

35 YR · Male

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

DEVICE UNABLE TO BE USED TO OBTAIN TEST RESULTS DUE TO SOFTWARE INCOMPATIBILITY WITH THE TESTING DEVICE. INSTRUCTIONS STATE TO WAIT FOR A COUNTER BUT NONE IS PRESENT. TEST UNIT FAILED TO CONNECT AND LOCKED COMMUNICATION WITHOUT PROVIDING APPLICABLE RECOVERY PROCEDURE TO USER.