BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALICE 6 LDX

    MDR report key: 15670946 · Received October 25, 2022

    Report

    Report Number
    2518422-2022-88077
    Event Type
    Malfunction
    Date Received
    October 25, 2022
    Date of Event
    October 15, 2022
    Report Date
    October 4, 2023
    Manufacturer
    RESPIRONICS,INC
    Product Code
    OLZ
    PMA / PMN Number
    K040595
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY BECAME AWARE OF A COMPLAINT WHILE USING AN ALICE 6 PSG SYSTEM. AFTER THE OVERNIGHT STUDY WAS PERFORMED, THE USER COMPLAINED OF AN ALLEGED RED MARK/ BURN MARKS ON THE FOREHEAD (FROM AN EEG GOLD CUP ELECTRODE) AND ON THE ARM FROM A MASIMO SPO2 SENSOR WHICH WAS VERY WORN. THE FOREHEAD REDNESS WAS FOUND TO BE FROM SCRATCHING THE AREA AFTER THE SENSOR WAS REMOVED, BUT THE DERMATOLOGIST FELT THE ARM BURN WAS MORE SEVERE THAN A BLISTER AND PRESCRIBED OINTMENT FOR THAT AREA. THERE WAS NO SERIOUS PATIENT HARM OR INJURY REPORTED. THE DEVICE HAS NOT YET RETURNED TO THE MANUFACTURER FOR EVALUATION. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED. SECTION(S) B1, B2, HAS CHANGED RELATED TO THE COMPLAINT CHANGING FROM THE REPORTED ADVERSE EVENT TO A PRODUCT PROBLEM. SECTION H1 HAS CHANGED TO REFLECT A MALFUNCTION. SECTION H6 HEALTH EFFECT- IMPACT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS HAS BEEN UPDATED. SECTION D9 CORRECTED IN THIS REPORT.

    Description of Event or Problem · 0

    THE MANUFACTURER BECAME AWARE OF A COMPLAINT WHILE USING AN ALICE 6 PSG SYSTEM. AFTER THE OVERNIGHT STUDY WAS PERFORMED, THE USER COMPLAINED OF ALLEGED RED MARKS/ BURN MARKS ON THE FOREHEAD (FROM AN EEG GOLD CUP ELECTRODE) AND ON THE ARM FROM A MASIMO SPO2 SENSOR WHICH WAS VERY WORN. THE FOREHEAD REDNESS WAS FOUND TO BE FROM SCRATCHING THE AREA AFTER THE SENSOR WAS REMOVED, BUT THE DERMATOLOGIST FELT THE ARM BURN WAS MORE SEVERE THAN A BLISTER AND PRESCRIBED OINTMENT FOR THAT AREA. THERE WAS NO SERIOUS PATIENT HARM OR INJURY REPORTED. THE DEVICE WITH ACCESSORIES HAS NOT YET BEEN RETURNED FOR INVESTIGATION. THE INVESTIGATION IS ON-GOING. A FOLLOW UP FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2510153 ALICE 6 LDX AUTOMATIC EVENT DETECTION SOFTWARE FOR POLYSOMNOGRAPH WITH ELECTROENCEPHALOGRAPH OLZ RESPIRONICS,INC RJP1063315

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other ALICE 6 SPO2 MASIMO PATIENT CABLE (HP/LPM) 1075383.