BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROCHE OMNI 1

    MDR report key: 2132668 · Received June 17, 2011

    Report

    Report Number
    1823260-2011-03321
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 27, 2011
    Report Date
    September 14, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CHL
    PMA / PMN Number
    K050423
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION OF THE RETURNED PART SHOWED THE CHOKE COILS OF THE VACUUM PUMP MOTOR WERE OVERHEATED BECAUSE OF A SHORT CIRCUIT IN THE VACUUM PUMP MOTOR. DUE TO THE CONSTRUCTION OF THE INSTRUMENT WITH NONFLAMMABLE AND FLAMEPROOF MATERIALS AND A HOUSING WHICH IS IN CONFORMITY WITH THE COMMON SAFETY REQUIREMENTS, THE RISK FOR PATIENTS, USERS AND ENVIRONMENT IN CASE OF THIS EVENT IS VERY REMOTE. NO OPERATOR OR PATIENT SAMPLES WERE AFFECTED. THE FIELD SERVICE REPRESENTATIVE REPAIRED THE INSTRUMENT BY REPLACING THE VACUUM PUMP UNIT.

    Description of Event or Problem · 1

    THE USER EXPERIENCED A BURNING SMELL AND UPON CHECKING THE ANALYZER FOUND THE VACUUM PUMP HAD A BURNT COIL. NO PATIENTS SAMPLES WERE INVOLVED IN THE EVENT AND NO ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE USER WAS NOT HARMED. THE FIELD SERVICE REPRESENTATIVE DETERMINED HE WOULD REPLACE THE VACUUM PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROCHE OMNI 1 BLOOD GAS ANALYZER CHL ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1