BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASP AUTOMATIC ENDOSCOPE REPROCESSOR

    MDR report key: 1365292 · Received March 6, 2009

    Report

    Report Number
    2150060-2009-00006
    Event Type
    Malfunction
    Date Received
    March 6, 2009
    Date of Event
    February 1, 2009
    Report Date
    February 4, 2009
    Manufacturer
    MINNTECH CORP.
    Product Code
    NVE
    PMA / PMN Number
    K832458
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER - TANK TEMPERATURE. CAPITAL EQUIPMENT, EVALUATED AT CUSTOMER SITE. THE FSE REPORTED THE FOLLOWING: THE TANK NOT REACHING THE APPROPRIATE TEMPERATURE. THE FSE REPLACED THE CONTROLLER PRINTED CIRCUIT BOARD (PCB). THE HARNESS AND THE HEATER WERE ALSO REPLACED. RESULT: OTHER - PCB, HARNESS.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THE UNIT DID NOT REACH THE CORRECT TEMPERATURE. THE CUSTOMER STATED THAT NO PATIENTS WERE INVOLVED. AN 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 AER EQUIPMENT NVE MINNTECH CORP. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA