BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENGUIN NUTRITIONAL WARMER

    MDR report key: 2598442 · Received May 24, 2012

    Report

    Report Number
    2598442
    Event Type
    Malfunction
    Date Received
    May 24, 2012
    Date of Event
    May 8, 2012
    Report Date
    May 8, 2012
    Manufacturer
    NEONATAL PRODUCT GROUP, INC.DBA CRECHE INNOVATION
    Product Code
    FPF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US

    Narratives

    Description of Event or Problem · 1

    AC (ALTERNATING CURRENT) POWER CORD WAS WIRED INCORRECTLY ON THE NEW UNIT. IT WAS FOUND THAT THE GROUND AND NEUTRAL WIRES WERE REVERSED.======================MANUFACTURER RESPONSE FOR BREAST MILK WARMER, PENGUIN NUTRITIONAL WARMER (PER SITE REPORTER).======================THE MANUFACTURER WAS ADVISED OF THE FINDING. THEY OFFERED TO REPLACE ALL POWER CORDS.OUT OF 26 NEW UNITS ONLY 1 POWER CORD WAS FOUND DEFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENGUIN NUTRITIONAL WARMER BREAST MILK WARMER FPF NEONATAL PRODUCT GROUP, INC.DBA CRECHE INNOVATION PNW-001-1.0 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *