BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD 100S STERILIZER

    MDR report key: 725840 · Received June 8, 2006

    Report

    Report Number
    2084725-2006-00070
    Event Type
    Malfunction
    Date Received
    June 8, 2006
    Date of Event
    May 22, 2006
    Report Date
    May 23, 2006
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    PMA / PMN Number
    K991999
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    H6: THE UNIT WAS SERVICED BY A CONTRACT SERVICE PROVIDER WHO REMOVED THE VAPORIZER PLATE DURING SERVICE BECAUSE HE FOUND THE PLATE TO BE CRACKED. HE INADVERTENTLY OMITTED TO PUT A REPLACEMENT PLATE IN PLACE. THE ISSUE HAS BEEN ADDRESSED WITH THE CONTACT SERVICE PROVIDER AND HOSP STAFF FOR CORRECTIVE AND PREVENATIVE ACTION. 510(K) IS K991999

    Description of Event or Problem · 1

    A WORKER EXPERIENCED A SMALL BURN ON THE INSIDE OF HER WRIST WHEN THE UNIT WAS CYCLED WITHOUT A VAPORIZER PLATE IN PLACE. THE SYMPTOMS RESOLVED AFTER IMMEDIATELY RINSING THE AFFECTED AREA UNDER RUNNING WATER. NO MEDICAL ATTENTION WAS SOUGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERRAD 100S STERILIZER STERILIZER MLR ADVANCED STERILIZATION PRODUCTS 10101 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN