MalfunctionMNR
ALICE NIGHTONE
Received Jan 20, 2026 · Event occurred May 6, 2025
Report 2518422-2026-002901 · MDR key 24116602
Device
Generic name
Ventilatory Effort Recorder
Manufacturer
Respironics, Inc.Model number
1133948Catalog number
1133948
Product problems
- Material Split, Cut or Torn
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
AN ALICE NIGHT ONE SLEEP DIAGNOSTICS DEVICE AS RETURNED TO A THIRD PARTY SERVICE CENTER FOR EVALUATION RELATED TO THE COMPLAINT OF XPOD WIRE SPLIT OPEN. THE DEVICE WAS VISUALLY INSPECTED. THE SERVICE TECHNICIAN REPORTS EXPOSED OR SPLIT WIRES ON THE SPO2 CABLE.