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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 136 03 15 000
Date submitted: 3/30/2015
Manufacturer:Natus Medical Inc.
Device Type:neoBLUE Blanket Systems
Description:Phototherapy Units, Visible Light, Hyperbilirubinemia
Medical Device Identifier:neoBLUE Blanket Systems
Units distributed since product release in 2011
Reason of Field Safety Corrective Action:Fiber-Optic Pads May Fail
Remedy Action:Identify any affected product in your inventory. If you have affected product, verify that you have received the Technical Bulletin letter from Natus. To inspect each pad before use, remove the pad from the light box, examine the cable end connector, and compare it to the following (see images in the attached FSN): Good Pad (Figure 1): A pad in good condition has a polished surface that is smooth to the touch, and the color of both the fibers and the fill material between the fibers is clear throughout. Failing Pad (Figure 2): A pad approaching failure will have a slightly noticeable degradation that feels rough to touch at the center of the smooth polished surface. Discoloration may or may not be apparent. Failed Pad (Figure 3): The surface degradation will eventually cause the fibers to melt and deform. Once this occurs the pad no longer provides the therapeutic treatment for which it is intended. If allowed to progress to this stage, the light box may also be damaged. If visible discoloration is observed and/or the fiber-optic bundle surface feels rough and uneven as described in Figure 2 above, discontinue use of the device and contact the Natus technical service department.
Athorized Representative/Importer/Distributor:Saudi Health Services Co. Ltd., Riyadh, (011) 26534455
Report Source:NCMDR
Source Ref. Number: DEEB7662202C1
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Natus Medical Inc..pdf