BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMEWOOD HEALTH CARE

    MDR report key: 2632569 · Received June 22, 2012

    Report

    Report Number
    MW5025958
    Event Type
    Malfunction
    Date Received
    June 22, 2012
    Date of Event
    March 29, 2012
    Report Date
    June 22, 2012
    Manufacturer
    HOMEWOOD HEALTH CARE
    Product Code
    NZG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PURCHASED APPROX 66 BASSINETS, MFR HOMEWOOD MODEL "CUSTOM MADE." WHILE STAFF MEMBER WAS MOVING BASSINET, HANDLE AND TOP PLATE FRACTURED FROM SUPPORT BASE. TOP PLATE IS WHAT HOLDS THE BABY; THIS HAD THE POTENTIAL OF DROPPING THE BABY OFF OF THE BASSINET. MFR WAS CONTACTED, THOROUGH EXAMINATION AND PICTURES WERE TAKEN. IT WAS DETERMINED THAT THERE WAS A STRUCTURAL FAILURE IN THE FASTENING OF THE TOP PLATE WHICH WAS INHERENT TO ALL BASSINETS. MFR RECALLED ALL BASSINETS. AN ATTEMPT WAS MADE TO RE-FASTEN TOP PLATE WITH AN ADDITIONAL CARRIAGE BOLT. THE "FIX" WAS INSUFFICIENT AND THE SAME ISSUE OCCURRED. CARRIAGE BOLT WAS ALSO PROTRUDING THROUGH THE TOP PLATE CREATING A HAZARD TO THE BABY'S HEAD. SECOND DESIGN FIX WAS THEN ATTEMPTED, COUNTER-SINKING THE EXISTING CARRIAGE BOLT AND ADDING TWO ADDITIONAL BOLTS TO THE HANDLE END OF BASSINET. THIS FIX BROUGHT THE BASSINETS BACK INTO OPERATION. IT WAS THEN DISCOVERED THAT THE WHEEL LOCKS WHEN BEING ENGAGED OR DISENGAGED WOULD SNAP OFF. WE WERE FORCED TO RETURN THE BASSINETS AT THAT POINT AND GET A DIFFERENT BASSINET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMEWOOD HEALTH CARE BASSINET NZG HOMEWOOD HEALTH CARE CUSTOM MADE FOR NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *