BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEPTUNE 2 ROVER ULTRA (120V)

    MDR report key: 1970364 · Received January 18, 2011

    Report

    Report Number
    1811755-2011-00156
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    December 21, 2010
    Report Date
    December 21, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    FYD
    PMA / PMN Number
    K012991
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED BY THE MFR'S FIELD SERVICE TECH AND THE REPORT IS PENDING. THIS REPORT WILL BE UPDATED WHEN ADD'L INFO IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ACCOUNT'S CASTER ON THE ROVER MADE IT DIFFICULT TO PUSH THE UNIT WHEN IT WAS FULL. A NURSE COMPLAINED OF BACK PAIN DUE TO THIS. IT WAS CONFIRMED THAT THERE WERE NO INJURY REPORTS SUBMITTED AND NO THERE WAS NO MEDICAL INTERVENTION REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEPTUNE 2 ROVER ULTRA (120V) AIR-HANDLING APPARATUS FOR A SURGICAL OPERATING RO FYD STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK