BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WATERS QUATTRO LCZ

    MDR report key: 2515163 · Received March 29, 2012

    Report

    Report Number
    3000221947-2012-00001
    Event Type
    Malfunction
    Date Received
    March 29, 2012
    Date of Event
    March 22, 2012
    Report Date
    March 29, 2012
    Manufacturer
    WATERS CORP.
    Product Code
    DOP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO WATERS AND IS CURRENTLY UNDER EVAL. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVAL.

    Description of Event or Problem · 1

    THE WATERS SERVICE ENGINEER REPORTED THAT WHILE SERVICING THE INSTRUMENT, THE ROUGHING PUMP BEGAN SMOKING. THE PUMP WAS UNPLUGGED AND A NEW PUMP WAS INSTALLED. NO INJURIES OCCURRED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WATERS QUATTRO LCZ DOP, MASS SPECTROMETER, CLINICAL USE DOP WATERS CORP. QUATTRO LCZ NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other