FDA Adverse Event
Malfunction
Summary report: N
ALICE 6
MDR report key: 21127217
·
Received January 10, 2025
Report
- Report Number
- 2518422-2025-100390
- Event Type
- Malfunction
- Date Received
- January 10, 2025
- Date of Event
- January 6, 2025
- Report Date
- June 2, 2026
- Manufacturer
- RESPIRONICS, INC.
- Product Code
- OLZ
- UDI-DI
- 00606959020702
- PMA / PMN Number
- K040595
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TU
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
THIS REPORT IS BEING SUBMITTED TO INCLUDE THE PRODUCT UDI.
Description of Event or Problem · 0
THIS REPORT IS BEING SUBMITTED TO INCLUDE THE PRODUCT UDI.
Description of Event or Problem · 0
THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE ALICE 6, BASE STATION SYSTEM, AND ALICE HEADBOX WERE USED WITH THE SLEEPSENSE THERMISTOR SENSOR ON THE DEVICE WHICH CAUSED BURNS ON THE FACE/CHEEK AREA OF THE PATIENT. THE THERMISTOR SENSOR WAS REPORTEDLY COMPLETELY WORN OUT AND EXPOSED INTERNAL WIRES. THERE WERE NO REPORTS OF MEDICAL INTERVENTION. THE MANUFACTURER IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 478789 | ALICE 6 | AUTOMATIC EVENT DETECTION SOFTWARE FOR POLYSOMNOGRAPH WITH ELECTROENCEPHALOGRAPH | OLZ | RESPIRONICS, INC. | 1063315 | 00606959020702 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male |