BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD 100S STERILIZATION SYSTEM

    MDR report key: 1003328 · Received February 27, 2008

    Report

    Report Number
    2084725-2008-00039
    Event Type
    Malfunction
    Date Received
    February 27, 2008
    Date of Event
    February 1, 2008
    Report Date
    February 1, 2008
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    PMA / PMN Number
    K991999
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN EMPLOYEE WITH HYDROGEN PEROXIDE CONTACT ON HER ABDOMEN FROM LIQUID THAT ROLLED OFF OF THE PACKAGE SHE WAS CARRYING. THE CUSTOMER STATED THAT THE EMPLOYEE RECEIVED A "BURN" WITH DISCOLORATION. THE EMPLOYEE WENT TO THE ER TO BE EXAMINED, BUT SHE WAS NOT PRESCRIBED ANY TREATMENT. THE EMPLOYEE REPORTED THAT BY THE TIME SHE GOT HOME FROM WORK THE DISCOLORATION WAS GONE. THE CUSTOMER REPORTED THAT THE CYCLE WAS COMPLETE, BUT SHE DID NOT KNOW IF THE VAPORIZER PLATE WAS IN PLACE. THE NEXT DAY THE CUSTOMER REPORTED THAT THE VAPORIZER PLATE WAS IN THE UNIT BUT NOT CORRECTLY INSTALLED AND REQUESTED SERVICE BECAUSE SHE BELIEVED THAT THE VAPORIZER PLATE HAD BEEN IN PLACE THE DAY BEFORE. THE ASP FIELD SERVICE ENGINEER (FSE) SPOKE TO THE CUSTOMER ON THE PHONE AND HAD HER INSTALL A NEW VAPORIZER PLATE. THE CUSTOMER RAN AN EMPTY CYCLE AND A CYCLE WITH A LOAD AND BOTH PASSED. THE CUSTOMER REQUESTED THAT THE FSE COME OUT AND CHECK THE UNIT. THE FSE PERFORMED A PRODUCT SPECIFICATION AND THE UNIT MET SPECIFICATIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK