BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTER

    MDR report key: 1386263 · Received March 10, 2009

    Report

    Report Number
    2084725-2009-00140
    Event Type
    Malfunction
    Date Received
    March 10, 2009
    Date of Event
    February 11, 2009
    Report Date
    February 11, 2009
    Manufacturer
    UNITROL/MINNTECH COR
    Product Code
    NVE
    PMA / PMN Number
    K832458
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACTUAL COMPONENT EVALUATED AT THE CUSTOMER SITE. THE FSE NOTED THAT GOOD WATER PRESSURE WAS COMING FROM SOURCE. HOWEVER, HE NOTICED THAT WEAK WATER PRESSURE GOING TO AER. THE FSE REPLACED FLOAT SWITCH AND REPLACED 2.0 FILTER. THE FSE RAN 3 CYCLES. THE UNIT MEETS SPECIFICATIONS. THE CUSTOMER CONTINUALLY HAS E01 ERRORS. CONCLUSION: DUE TO REPEATED E01 FAILURES OBSERVED AT CERTAIN CUSTOMER SITES, A CAPA WAS GENERATED TO INVESTIGATE THE ROOT CAUSES.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THAT THE UNIT WAS LEAKING CIDEX OPA FROM THE FRONT RIGHT CORNER. THE CUSTOMER HAS BEEN PROCESSING FUJINON SCOPES. THERE WERE NO REPORTS OF PHYSICAL INJURIES RELATED TO THE LEAK. A 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 AER EQUIPMENT NVE UNITROL/MINNTECH COR NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA CIDEX OPA: CATALOG#: 20390| 200/400 SERIES FUJINON SCOPES