BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEWBORN BASSINETS

    MDR report key: 1564281 · Received November 24, 2009

    Report

    Report Number
    1564281
    Event Type
    Malfunction
    Date Received
    November 24, 2009
    Date of Event
    November 4, 2009
    Report Date
    November 24, 2009
    Manufacturer
    NEMSCHOFF
    Product Code
    NZG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US

    Narratives

    Description of Event or Problem · 1

    SINCE EARLY WINTER THIS YEAR, WE HAVE HAD PROBLEMS WITH OUR NEWBORN BASSINETS CRACKING, BREAKING, AND DEVELOPING HOLES IN THE CORNERS. DRAWERS/DOORS SWING OPEN AND WON'T STAY CLOSED, CARTS HARD TO PUSH, WHEELS DON'T ROLL SMOOTHLY. PLEXIGLASS PIECE ALONG THE TOP OF THE BASSINETS WERE ALL REPLACED BY THE COMPANY APPROXIMATELY FOUR MONTHS AGO. CURRENTLY HAVE 11 BASSINETS NOT USABLE. HAVE PICTURES OF PROBLEMS I CAN SEND. MANUFACTURER RESPONSE (AS PER REPORTER) FOR BASSINETS THAT FIT INTO WOODEN CARTS, NEWBORN BASSINETS: INITIALLY THE COMPANY STATED THAT THE CARTS/BASSINETS WERE NOT BEING HANDLED CORRECTLY. PLEXIGLASS PARTS WERE REPLACED AND THEY ARE ALL BREAKING/CRACKING AGAIN. REPRESENTATIVE CAME AGAIN AND TOOK PICTURES AND I TOOK PICTURES. WE ASKED IF ANY OTHER FACILITY WAS HAVING A PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEWBORN BASSINETS BASSINET, INFANT NZG NEMSCHOFF * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *