BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEMSCHOFF PERINATAL BASSINET

    MDR report key: 2380239 · Received August 15, 2011

    Report

    Report Number
    3008746933-2011-00001
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    April 7, 2010
    Report Date
    April 8, 2010
    Manufacturer
    NEMSCHOFF
    Product Code
    NZG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CAPA INVESTIGATION OF BASSINET DRAWER OPENING IS ONGOING. WE ARE SUBMITTING THIS MEDWATCH 3500A FORM AS ADVISED BY THE MDR POLICY BRANCH (TELEPHONE CALL 08/11/2011). ADDITIONALLY, THE CALLER DID NOT SPECIFY THE NUMBER OF BASSINETS ON WHICH DRAWERS OPENED. A TOTAL OF 5 UNITS WERE SHIPPED TO THIS USER FACILITY. PER ADVICE OF MDR POLICY BRANCH (08/11/2011) ,WE ARE SUBMITTING ONE MEDWATCH REPORT WITH RESPECT TO THIS EVENT.

    Description of Event or Problem · 1

    DRAWERS OPEN WHEN BASSINETS ARE ROLLING AND GOING AROUND A CORNER. END USER IS CONCERNED THIS WILL HAPPEN WITH BABY ON BOARD AND CART COULD POTENTIALLY FLIP. CALLER DID NOT REPORT THAT THE PRODUCT TIPPED OR ANY PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEMSCHOFF PERINATAL BASSINET BASSINET, HOSPITAL NZG NEMSCHOFF BSNT02W 113507-149598004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other