MalfunctionMNR
RENTAL - ALICE NIGHTONE N.A. WIRELESS
Received Jan 9, 2026 · Event occurred Dec 30, 2025
Report 2518422-2026-001357 · MDR key 24021330
Device
Generic name
Ventilatory Effort Recorder
Manufacturer
Respironics, Inc.Model number
R1113277Catalog number
R1113277
Product problems
- Material Split, Cut or Torn
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THIS NOTIFICATION WAS OPENED FOR REVIEW DUE TO AN ALLEGATION ALICE NIGHTONE DEVICE BEING DAMAGED WITH SAO2 CORD BEING BROKEN AND WIRES BEING EXPOSED. THERE WAS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. THIS EVENT IS REPORTABLE UNDER FDA 21 CFR PART 803 AS IT MEETS THE CRITERIA FOR A SERIOUS INJURY AND/OR PRODUCT MALFUNCTION.