BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WATERS QUATTRO PREMIER XE

    MDR report key: 2833426 · Received October 26, 2012

    Report

    Report Number
    9616673-2012-00002
    Event Type
    Malfunction
    Date Received
    October 26, 2012
    Date of Event
    October 8, 2012
    Report Date
    October 8, 2012
    Manufacturer
    WATERS CORPORATION
    Product Code
    OQS
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A WATERS FIELD SERVICE ENGINEER (FSE) INSPECTED THE INSTRUMENT. THE FSE FOUND THAT THE CABLES WERE NOT DAMAGED OR EXPOSED AND WERE IN THE CORRECT POSITIONS. THE CUSTOMER REPORTED THAT THE SHOCK WAS FROM THE LID. THROUGHOUT THE COURSE OF THE EVALUATION, THE FSE TOUCHED THE LID AND MANY OTHER PARTS OF THE INSTRUMENT AND DID NOT EXPERIENCE ANY ELECTRICAL DISCHARGE. NO SIMILAR COMPLAINTS HAD BEEN MADE BY THIS CUSTOMER PRIOR TO THIS REPORTED EVENT AND NO SIMILAR ISSUES HAVE BEEN REPORTED SINCE. NO ISSUES WERE FOUND WITH THE DEVICE AND NO INJURY WAS REPORTED. WE CONSIDER THIS REPORT COMPLETE. HOWEVER, IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE USER EXPERIENCED "A COUPLE" OF ELECTRIC SHOCKS WHEN TOUCHING THE BODY OF THE INSTRUMENT. THE USER DID NOT REPORT ANY INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WATERS QUATTRO PREMIER XE DOP, MASS SPECTROMETER, CLINICAL USE OQS WATERS CORPORATION QUATTRO PREMIER XE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA