ALICE NIGHTONE
Received Jan 27, 2026 · Event occurred May 6, 2025
Report 2518422-2026-003317 · MDR key 24190072
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
Additional Manufacturer Narrative
THE MANUFACTURER PREVIOUSLY REPORTED INFORMATION RELATED TO AN ALICE NIGHTONE SLEEP DIAGNOSTICS DEVICE. THE CUSTOMER COMPLAINT WAS UNIT IS NOT RECORDING PROPERLY. THE DEVICE WAS RETURNED TO A THIRD PARTY SERVICE CENTER. THE SERVICE TECHNICIAN VISUALLY INSPECTED THE DEVICE. THE TECHNICIAN REPORTS DAMAGES TO THE SPO2 CABLE (CABLE INSULATION DAMAGE, WIRES EXPOSED, SPLITTING WIRES EXPOSED, CUT CABLE). CORRECTION: THIS EVENT IS NO LONGER CONSIDERED REPORTABLE BASED ON THE RISK ASSESSMENT.
Description of Event or Problem
THE MANUFACTURER RECEIVED INFORMATION RELATED TO AN ALICE NIGHTONE SLEEP DIAGNOSTICS DEVICE. THE CUSTOMER COMPLAINT WAS UNIT IS NOT RECORDING PROPERLY. THE DEVICE WAS RETURNED TO A THIRD PARTY SERVICE CENTER. THE SERVICE TECHNICIAN VISUALLY INSPECTED THE DEVICE. THE TECHNICIAN REPORTS DAMAGES TO THE SPO2 CABLE (CABLE INSULATION DAMAGE, WIRES EXPOSED, SPLITTING WIRES EXPOSED, CUT CABLE). A FINAL REPORT IS BEING SUBMITTED. IF NEW INFORMATION BECOMES AVAILABLE, A FOLLOW UP/SUPPLEMENTAL REPORT MAY BE COMPLETED.