BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATIC ENDOSCOPE REPROCESSOR

    MDR report key: 1231053 · Received October 30, 2008

    Report

    Report Number
    2084725-2008-00715
    Event Type
    Malfunction
    Date Received
    October 30, 2008
    Date of Event
    September 25, 2008
    Report Date
    September 25, 2008
    Manufacturer
    MINNTECH CORP.
    Product Code
    NVE
    PMA / PMN Number
    K832458
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER FOUND A CRACK IN THE RESERVOIR TANK. THE CUSTOMER PUT PUTTY TO SEAL THE CRACK. CUSTOMER REPAIRED UNIT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WAS CIDEX LEAKING FROM THE HEATER. THE CUSTOMER DID NOT WANT TO ORDER A NEW RESERVOIR TANK. THE CUSTOMER PUT PUTTY ON THE CRACK AND THE UNIT STOPPED LEAKING. THERE WERE NO REPORTS OF PHYSICAL COMPLAINTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATIC ENDOSCOPE REPROCESSOR AER EQUIPMENT NVE MINNTECH CORP. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA