BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PSORALITE COM FLEX JOULEE 4.1

    MDR report key: 3070 · Received July 30, 1992

    Report

    Report Number
    3070
    Event Type
    Injury
    Date Received
    July 30, 1992
    Date of Event
    November 18, 1991
    Report Date
    February 21, 1992
    Manufacturer
    PSORALITE CORPORATION
    Product Code
    FTC
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    PHOTOTHERAPY TERMINOLOGY:UVA-ULTRAVIOLET A, A DEEP PENETRATING UV TREATMENTUVB-ULTRAVIOLET B, A SKIN SURFACR UV TREATMENTPUVA-PSORALEN ULTRAVIOLET A, THE PATIENT IS MEDICATED WITH PSORALEN AND THEN TREATED WITH UVATHE PATIENT CAME TO THE DERMATOLOGY DEPARTMENT FOR PHOTOTHERAPY TREATMENT. HIS CHART WAS REVIEWED, THE MACHINE WAS PROGRAMMED FOR UVB AND THE TREATMENT WAS INITIATED. AN ERROR WAS DISCOVERED AND THE UNIT WAS STOPPED AFTER FIVE SECONDS OF TREATMENT. THE MACHINE WAS THEN TURNED OFF WITH THE KEY AND WAS REPROGRAMMED FOR UVA. IT WAS DISCOVERED AT THE COMPLETION OF THE UVA TREATMENT THAT THE UVB PROGRAMMING DID NOT CLEAR, SO THE PATIENT RECEIVED BOTH UVA AND UVB.THE DOCTOR WAS CALLED AND THE PATIENT WAS TREATED FOR DIFFUSE REDNESS RELATED TO UVB EXPOSURE. BIOMEDICAL ENGINEERING INDICATED THAT THE EQUIPMENT WAS IN WORKING ORDER, SO THE ERROR WAS DETERMINED TO BE OF A PROCEDURAL NATURE. THE MANUFACTURER WAS CONTACTED AND SUGGESTED INSTALLING A NEW PANEL WHICH WOULD INCLUDE SAFETY FEATURES TO PREVENT A REPEAT OF THIS TYPE OF INCIDENT. THE PANEL WAS INSTALLED AND BIOMEDICAL ENGINEERING WILL TRACK THIS INCIDENT AS PART OF ITS QUALITY ASSURANCE PROGRAM, AS WILL THE SAFETY COMMITTEE.DEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-SEP-91. SERVICE PROVIDED BY: MANUFACTURER. SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE NOT USED AS LABELED/INDENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, ELECTRICAL TESTS PERFORMED, PERFORMANCE TESTS PERFORMED. RESULTS OF EVALUATION: DESIGN, FAILURE TO FOLLOW INSTRUCTIONS, INVALID DATA. CONCLUSION: SOFTWARE/FIRMWARE CONTRIBUTED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE REPAIRED AND PUT BACK IN SERVICE, DEVICE TEMPORARILY REMOVED FROM SERVICE, USE OF ALL SIMILAR DEVICES STOPPED TEMPORARILY. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PSORALITE COM FLEX JOULEE 4.1 PUVA UNIT FTC PSORALITE CORPORATION 55000 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention