BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEPTUNE ROVER WITHOUT SMOKE EVAC AND POWER POLE

    MDR report key: 2006088 · Received February 22, 2011

    Report

    Report Number
    1811755-2011-00566
    Event Type
    Malfunction
    Date Received
    February 22, 2011
    Date of Event
    July 2, 2010
    Report Date
    July 2, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    FYD
    PMA / PMN Number
    K012991
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE TECH REPORTED THAT WHILE HE WAS AT THE ACCOUNT FOR A DIFFERENT REPAIR, HE WAS ASKED TO LOOK AT A ROVER WITH A PLUG THAT HAD EXPOSED WIRES. WHEN THE TECH MET WITH THE HOSP OPERATING ROOM EQUIPMENT MGR, SHE INFORMED THE TECH THAT THE BIOMED HAD ALREADY REPLACED THE PLUG.

    Description of Event or Problem · 1

    THE FIELD SERVICE REPAIR TECH REPORTED THAT THE ACCOUNT HAD A NEPTUNE UNIT THAT HAD EXPOSED WIRES ON THE POWER CORD. THERE WAS NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEPTUNE ROVER WITHOUT SMOKE EVAC AND POWER POLE AIR-HANDLING APPARATUS FOR A SURGICAL OPERATING RO FYD STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK