BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BASSINET

    MDR report key: 2522621 · Received April 2, 2012

    Report

    Report Number
    MW5024902
    Event Type
    Injury
    Date Received
    April 2, 2012
    Date of Event
    March 20, 2012
    Report Date
    April 2, 2012
    Manufacturer
    NEMSCHOFF, INC.
    Product Code
    NZG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BASSINET USED BY HOSPITAL HAD A RECALL ON THE (4) SWIVEL CASTER BASE. THE RECALL REQUIRED ONE WHEEL TO BE STATIONARY. THIS CHANGE MADE PUSHING/STEERING THE BASSINET EXTREMELY DIFFICULT. HEALTH CARE PROFESSIONALS HAVE SUSTAINED INJURIES FOLLOWING THIS CHANGE. ADDITIONALLY, WHEN THE PT ATTEMPTS TO PULL THE BASSINET TOWARD HER, THE CLEAR TUB PARTIALLY TIPS AS A RESULT OF THE STATIONARY WHEEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BASSINET NZG NEMSCHOFF, INC. BSNT/01
    2 BASSINET NZG NEMSCHOFF, INC. BSNT/02
    3 BASSINET NZG NEMSCHOFF, INC. BSNT/03

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention