BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALICE 6, LDXS HEADBOX

    MDR report key: 23413408 · Received October 29, 2025

    Report

    Report Number
    2518422-2025-050129
    Event Type
    Malfunction
    Date Received
    October 29, 2025
    Date of Event
    March 9, 2022
    Report Date
    March 31, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    OLZ
    UDI-DI
    00606959407145
    PMA / PMN Number
    K040595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY RECEIVED INFORMATION FROM CUSTOMER IN REFERENCE TO AN ALICE 6, LDXS HEADBOX WITH AN ALLEGATION OF END RENTAL LOANER. THERE WAS NO REPORT OF SERIOUS INJURY OR HARM. THERE WAS NO MEDICAL INTERVENTION SPECIFIED. THE DEVICE WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER AND OBSERVED THE PCA WITH ELECTRICAL DAMAGE AND ADDITIONAL FAILURES WAS OBSERVED. THE CUSTOMER COMPLAINT WAS NOT REPRODUCED. THERE WAS CHEST STEP ERROR CODE BEEN IDENTIFIED. PLEASE NOTE THAT FOLLOWING FURTHER REVIEW OF COMPLAINT INFORMATION AND DEVICE EVALUATION PERFORMED BY THE THIRD-PARTY SERVICE CENTER IT WAS CONFIRMED THAT THERE WAS NO VISIBLE PHYSICAL ELECTRICAL DAMAGE TO THE PCBA/PCA. ANALYSIS OF PAST EVENTS HAS NOT INDICATED AN ADVERSE EVENT HAS OCCURRED DUE TO THE REPORTED ALLEGATION. THE DEVICE EVALUATION FOUND NO EVIDENCE OF PRODUCT MALFUNCTION IN WHICH THE ABILITY OF THE DEVICE TO DELIVER THE PRESCRIBED THERAPY TO THE PUBLISHED SPECIFICATIONS WOULD BE IMPACTED. IN ADDITION, THERE IS NO EVIDENCE THAT THE DEVICE MALFUNCTIONED IN A MANNER THAT WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY IF IT WERE TO RECUR. REVIEW OF THE RISK FILE INDICATES THE POTENTIAL FOR A SERIOUS ADVERSE EVENT OCCURRING AS A RESULT OF THIS INCIDENT IS UNLIKELY. THIS EVENT IS NOT REPORTABLE UNDER FDA 21 CFR PART 803 AS IT DOES NOT MEET THE CRITERIA FOR A DEATH, SERIOUS INJURY AND/OR REPORTABLE PRODUCT MALFUNCTION.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION FROM CUSTOMER IN REFERENCE TO AN ALICE 6, LDXS HEADBOX WITH AN ALLEGATION OF END RENTAL LOANER. THERE WAS NO REPORT OF SERIOUS INJURY OR HARM. THERE IS NO MEDICAL INTERVENTION WAS SPECIFIED. THE DEVICE WAS RETURNED TO THE THIRD-PARTY SERVICE CENTRE. AND OBSERVED THE PCA WITH ELECTRICAL DAMAGE AND ADDITIONAL FAILURES WAS OBSERVED. THE CUSTOMER COMPLAINT WAS NOT REPRODUCED. THERE WAS CHEST STEP ERROR CODE HAS BEEN IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215159 ALICE 6, LDXS HEADBOX STANDARD POLYSOMNOGRAPH WITH ELECTROENCEPHALOGRAPH OLZ RESPIRONICS, INC. R1063552 00606959407145

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown