BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER

    MDR report key: 1203249 · Received October 17, 2008

    Report

    Report Number
    2084725-2008-00664
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Date of Event
    September 26, 2008
    Report Date
    September 26, 2008
    Manufacturer
    MINNTECH CORPORATION
    Product Code
    NVE
    PMA / PMN Number
    K832458
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (OTHER, SOLUTION SPILL) - CAPITAL EQUIPMENT, EVALUATED AT CUSTOMER SITE. THE FSE FOUND SYSTEM NOT IN USE. THE FSE TROUBLESHOT AND FOUND TANK ASSEMBLY CRACKED AT THE FRONT OF TANK. CUSTOMER DECLINED REPAIRS AT THIS TIME. RESULTS - TANK. CONCLUSION: CUSTOMER DECLINED REPAIRS AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE UNIT WAS LEAKING CIDEX OPA. THERE WERE NO REPORTS OF INJURIES. THE ASP FIELD SERVICE ENGINEER (FSE) WENT TO THE FACILITY TO ASSESS THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER ENDOSCOPE REPROCESSOR NVE MINNTECH CORPORATION NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA