BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HITACHI 911

    MDR report key: 34665 · Received July 29, 1996

    Report

    Report Number
    MW1009586
    Event Type
    Malfunction
    Date Received
    July 29, 1996
    Date of Event
    April 30, 1996
    Report Date
    July 26, 1996
    Manufacturer
    BOEHRINGER-MANNHEIM CORP.
    Product Code
    JJC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SV-12 INPUT NIPPLE LEAKED WASH REAGENT (NAOH). DUE TO PLACEMENT OF THIS CONNECTION, NAOH CONTACTED HOUSING OF VACUUM PUMP DESTROYING HOUSING, RESULTING IN ANALYZER FAILURE. RAPID IDENTIFICATION OF PROBLEM BY TECHNOLOGIST PREVENTED POSSIBLE FIRE. THE DESIGN OF THE INSTRUMENT PRESENTS A SIGNIFICANT SAFETY RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HITACHI 911 AUTOMATED CHEMISTRY ANALYZER JJC BOEHRINGER-MANNHEIM CORP. 911

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other