BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NARA, DOMESTIC

    MDR report key: 8066966 · Received November 13, 2018

    Report

    Report Number
    0001831750-2018-01430
    Event Type
    Malfunction
    Date Received
    November 13, 2018
    Date of Event
    October 19, 2018
    Report Date
    November 13, 2018
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    NZG
    UDI-DI
    07613327261615
    Removal / Correction Number
    PR 1814402
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NARA MATTRESS WAS EXPANDED DUE TO THE HIGH ALTITUDE. THERE WAS PATIENT INVOLVEMENT, HOWEVER NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    902504 NARA, DOMESTIC BASSINET, HOSPITAL NZG STRYKER MEDICAL-KALAMAZOO 07613327261615

    Patients

    Seq Age Sex Outcome Treatment
    1