BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 400 PLUS

    MDR report key: 4113589 · Received September 24, 2014

    Report

    Report Number
    1823260-2014-07268
    Event Type
    Malfunction
    Date Received
    September 24, 2014
    Date of Event
    September 13, 2014
    Report Date
    October 29, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    THE MOST LIKELY CAUSE OF THIS EVENT WAS ACCUMULATION OF DUST IN THE POWER SUPPLY. MAINTENANCE DOCUMENTATION INCLUDES CLEANING INSTRUCTIONS RELATED TO DUST BUILD UP. THE POWER SUPPLY WAS REPLACED WITH A NEWER TYPE ON (B)(6) 2014. THE INSTRUMENT HAS WORKED WITHOUT PROBLEMS SINCE THE REPLACEMENT.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THEY FOUND THEIR INTEGRA 400 PLUS ANALYZER COMPLETELY TURNED OFF IN THE MORNING. THEY TRIED TO POWER UP THE ANALYZER, BUT THE "ELECTRICITY PROTECTION INTERVENED". THE CUSTOMER STATED THEY COULD SMELL A BURNING SMELL, AND IT WAS IMPOSSIBLE TO TURN THE ANALYZER ON. THE ANALYZER WAS SWITCHED OFF AFTER THIS INCIDENT. PICTURES WERE PROVIDED SHOWING PHYSICAL DAMAGE, POSSIBLY DUE TO EXCESSIVE HEAT. THE FIELD SERVICE REPRESENTATIVE REPLACED THE OLD POWER SUPPLY. NO ONE WAS ADVERSELY AFFECTED BY THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596046 COBAS INTEGRA 400 PLUS CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1