BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BASSINET, MODERN STYLE

    MDR report key: 2022022 · Received March 10, 2011

    Report

    Report Number
    1831750-2011-02366
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    February 14, 2011
    Report Date
    February 14, 2011
    Manufacturer
    STRYKER MEDICAL
    Product Code
    FMS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SHIPPING DAMAGE.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE BASSINET ARRIVED AT THE HOSPITAL WITH ONE OF THE CASTERS RIPPED OFF THE UNIT. THE PARTICLE BOARD AROUND THE CASTER WAS SMASHED AND RIPPED OUT AS WELL. NO PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BASSINET, MODERN STYLE MANUAL PATIENT TRANSFER DEVICE FMS STRYKER MEDICAL 4400124000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA