BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NARA, DOMESTIC

    MDR report key: 6912303 · Received October 3, 2017

    Report

    Report Number
    0001831750-2017-00430
    Event Type
    Malfunction
    Date Received
    October 3, 2017
    Date of Event
    September 5, 2017
    Report Date
    March 27, 2018
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    NZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUPPLEMENTAL SUBMITTED TO INCLUDE UDI.

    Additional Manufacturer Narrative · 1

    IT WAS DETERMINED DURING THE EVALUATION THAT THE BASE WAS BENT, CAUSING THE CASTERS TO BE LOOSE/WOBBLY, WHICH RESULTED IN THE UNIT BEING DIFFICULT TO MANEUVER. THIS ISSUE IS NOT LIKELY TO CAUSE OR CONTRIBUTE TO SERIOUS INJURY OR DEATH IF IT WAS TO RECUR AND IS, THEREFORE, NOT REPORTABLE. THE ISSUE WAS RESOLVED FOR THE CUSTOMER BY SCRAPPING THE UNIT AS THE BENT FRAME WAS FOUND TO BE UNREPAIRABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CASTERS ARE LOOSE/WOBBLY. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CASTERS ARE LOOSE/WOBBLY. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CASTERS ARE LOOSE/WOBBLY. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689356 NARA, DOMESTIC BASSINET, HOSPITAL NZG STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1