BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER

    MDR report key: 1082506 · Received July 24, 2008

    Report

    Report Number
    2084725-2008-00407
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    May 19, 2008
    Report Date
    May 19, 2008
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    FEB
    PMA / PMN Number
    K832458
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FSE CONTACTED THE CUSTOMER, AND DETERMINED THAT THE CIDEX OPA TANK WAS DAMAGED AT HEATER BOSS. THE CUSTOMER REPAIRED THE TANK ASSEMBLY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED LEAKING OF CIDEX OPA FROM THEIR AER. THE CUSTOMER STATED THAT THERE WERE NO PHYSICAL COMPLAINTS REPORTED. THE ASP FIELD SERVICE ENGINEER (FSE) CONTACTED THE CUSTOMER BY PHONE TO DETERMINE THE CAUSE OF THE LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER ENDOSCOPE REPROCESSOR FEB ADVANCED STERILIZATION PRODUCTS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA CIDEX OPA