BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD

    MDR report key: 1361112 · Received January 29, 2009

    Report

    Report Number
    2084725-2008-00870
    Event Type
    Malfunction
    Date Received
    January 29, 2009
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    Product Problem
    Yes
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MODEL NUMBERS 10050, 10100, 10101, 10104, 10113, 14100, 10201, 10217, 10201-002, AND 10202-002. CATALOG # 10033: 218 EVENTS. CATALOG # 10050: 5 EVENTS. CATALOG # 10101: 25 EVENTS. CATALOG # 10104: 1 EVENT. CATALOG # 10113: 1 EVENT. CATALOG # 14100: 1 EVENT. CATALOG # 10201: 3 EVENTS. CATALOG # 10217: 6 EVENTS. CATALOG # 10201-002: 9 EVENTS. CATALOG # 100202-002 - 3 EVENTS. THE 272 REPORTS OF ADVERSE EVENTS ASSOCIATED WITH STERRAD STERILIZATION SYSTEMS. THE PREDOMINANT EVENT TYPE IS OIL MIST / HAZE. THE 272 REPORTED EVENTS WERE IDENTIFIED FROM A RETROSPECTIVE REVIEW OF COMPLAINTS RECEIVED FROM 08/28/06 TO 08/31/08. SEE SCANNED PAGES.

    Description of Event or Problem · 1

    EIGHTY NIGHT REPORTS OF MALFUNCTION EVENTS ASSOCIATED WITH DAMAGED DEVICE FROM STERRAD UNITS. THREE REPORTS OF MALFUNCTION EVENTS ASSOCIATED WITH H2O2 RESIDUE FROM STERRAD NX. ELEVEN REPORTS OF MALFUNCTION EVENTS ASSOCIATED WITH OIL MIST ISSUES FROM STERAD 100S. THREE REPORTS OF MALFUNCTION EVENTS ASSOCIATED WITH OIL MIST ISSUES FROM STERAD 50. TEN REPORTS OF MALFUNCTION EVENTS ASSOCIATED WITH OIL MIST ISSUES FROM STERAD 200. ONE HUNDRED SEVENTEEN REPORTS OF MALFUNCTION EVENTS ASSOCIATED WITH OIL MIST ISSUES FROM STERAD NX. THIRTY NINE REPORTS OF HUMAN REACTIONS ASSOCIATED WITH STERRAD UNITS. THESE EVENTS WERE NOT RELATED TO ANY REMEDIAL ACTIONS TAKEN BY ASP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERRAD STERILIZER, MEDICAL DEVICE MLR ADVANCED STERILIZATION PRODUCTS 10033

    Patients

    Seq Age Sex Outcome Treatment
    1