BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WATERS QUATTRO PREMIER

    MDR report key: 2862172 · Received December 5, 2012

    Report

    Report Number
    9616673-2012-00003
    Event Type
    Malfunction
    Date Received
    December 5, 2012
    Date of Event
    November 9, 2012
    Report Date
    November 9, 2012
    Manufacturer
    WATERS CORP.
    Product Code
    DOP
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON INFORMATION REPORTED BY THE CUSTOMER, THE INSTRUMENT WAS NOT FUNCTIONING WHEN THEY ARRIVED IN THE MORNING. THERE WERE BURN MARKS ON THE FLOOR, BUT THE LAB SPRINKLERS DID NOT GO OFF. NO INJURIES WERE REPORTED. THE ROTARY INTERLOCK SWITCHBOX FROM THE DEVICE WAS RETURNED TO WATERS. A SUPPLEMENTAL MDR WILL BE SENT WHEN THE RESULTS OF THE INVESTIGATION OF THE RETURNED COMPONENT ARE COMPLETED.

    Description of Event or Problem · 1

    THE USER REPORTED THAT THEY FOUND THE SYSTEM SHUT DOWN WHEN THEY ARRIVED IN THE MORNING. THE CUSTOMER SAID THE ROTARY INTERLOCK BOX WAS BURNED AND THAT THERE WERE BURN MARKS ON THE FLOOR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA