BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALICE 5 SYSTEM

    MDR report key: 5980602 · Received September 27, 2016

    Report

    Report Number
    2518422-2016-03823
    Event Type
    Injury
    Date Received
    September 27, 2016
    Date of Event
    October 13, 2015
    Report Date
    November 8, 2016
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    OLZ
    PMA / PMN Number
    K040595
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER RECEIVED INFORMATION THAT THE ALICE 5 POLYSOMNOGRAPHY DEVICE IS NOT IMPLICATED IN THE PATIENT'S ALLEGED INJURY. THE USER FACILITY CONFIRMED THAT THE DEVICE WAS NEVER TAKEN OUT OF SERVICE, HAS BEEN USED ON OTHER PATIENTS SINCE THE REPORTED EVENT, AND THERE HAVE BEEN NO ISSUES. CONFIRMATION OF THE SERIAL NUMBER WAS RECEIVED FROM THE USER FACILITY, THEREFORE THE MATERIAL NUMBER, CATALOG NUMBER, AND SERIAL NUMBERS HAVE BEEN UPDATED ACCORDINGLY ON THIS REPORT. NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFORMATION FROM A LAW FIRM THAT A "RESPIRONICS PRODUCT ALICE 5 PSG POLYSOMNOGRAPHY MALFUNCTIONED AND CAUSED BURNING TO PLAINTIFF'S SKIN AND PERMANENT DISFIGUREMENT TO HIS FACE". THERE WAS NO OTHER INFORMATION REGARDING THE ALLEGED INJURY OR MEDICAL INTERVENTION REQUIRED. INFORMATION RECEIVED INDICATES THE PLAINTIFF'S ALLEGED EVENT MAY HAVE OCCURRED AT (B)(6) ON APPROXIMATELY (B)(6) 2015. THERE IS NO INDICATION THE MANUFACTURER WAS NOTIFIED OF THIS ALLEGED EVENT AT THE TIME. A SEARCH OF THE MANUFACTURER'S COMPLAINT SYSTEM YIELDED NO SIMILAR COMPLAINTS. THE ALICE 5 SYSTEM IS A POLYSOMNOGRAPHY SYSTEM THAT IS INTENDED TO RECORD, DISPLAY,AND PRINT PHYSIOLOGICAL INFORMATION FOR CLINICIANS OR PHYSICIANS. THESE PARAMETERS ARE PRESENTED GRAPHICALLY ON A COMPUTER SCREEN FOR DIAGNOSTIC REVIEW SIMILAR IN APPLICATION TO THE USE OF A TRADITIONAL PAPER-BASED POLYGRAPH RECORDER. THE DEVICE IS USED IN HOSPITALS, INSTITUTIONS, SLEEP CENTER OR CLINICS, OR OTHER TEST ENVIRONMENTS WHERE ADULT OR INFANT PATIENTS REQUIRE THE DOCUMENTATION OF VARIOUS SLEEP OR OTHER PHYSIOLOGICAL DISORDERS. THE ALICE 5 EQUIPMENT COLLECTS THE DATA FROM SENSORS PLACED ON A PATIENT AND DELIVERS THE DATA TO A COMPUTER RUNNING THE SLEEPWARE APPLICATION. THE ALICE SLEEPWARE APPLICATION IS A (B)(6) BASED SOFTWARE PROGRAM DESIGNED TO MONITOR, DISPLAY, PROCESS, AND DOWNLOAD POLYSOMNOGRAPHIC DATA RECORDED WITH THE ALICE 5 EQUIPMENT. THERE WAS NO SERIAL NUMBER OR MATERIAL NUMBER PROVIDED FOR THE ALICE 5 SYSTEM. A MATERIAL NUMBER IS BEING ASSIGNED FOR THIS REPORT, BUT MAY CHANGE IF A SERIAL NUMBER OR MATERIAL NUMBER ARE OBTAINED AND CONFIRMED. THE MANUFACTURER'S INVESTIGATION IS ON-GOING. REQUESTS HAVE BEEN MADE FOR ADDITIONAL INFORMATION AND THE RETURN OF THE DEVICE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631455 ALICE 5 SYSTEM ELECTROENCEPHALOGRAPH/POLYSOMNOGRAPHY SYSTEM OLZ RESPIRONICS, INC. C1068726

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability