SFDA National Center for Medical Devices Reporting

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Medical Devices Sector قطاع الأجهزة الطبية	NCMDR National Center for Medical Devices Reporting المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
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NCMDR Recall

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Reference Number:	mdprc 042 12 17 000
Date submitted:	12/12/2017

Manufacturer:	GE Healthcare
Device Type:	Lullaby Resus plus
Description:	T-piece resuscitation
Medical Device Identifier:	All Lullaby RESUS Plus Systems -Part number: 2070100-001 (Lullaby Resus Plus - NIST) & 2070100-002 (Lullaby Resus Plus- DISS)
Reason of Field Safety Corrective Action:	GE Healthcare has recently become aware of a potential issue related to inaccurate manometer reading of Lullaby Resus Plus devices when used for T-piece resuscitation. During the neonatal resuscitation process using T-piece on Resus Plus devices, the Manometer shows higher PEEP reading than actual maintained at the end of T-piece. Less than expected PEEP may lead to insufficient ventilation. There have been no injuries reported as a result of this issue.
Remedy Action:	GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for the correction.
Athorized Representative/Importer/Distributor:	GE Healthcare
Report Source:	NCMDR
Source Ref. Number:	8B1418B7511BF
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	GE Healthcare.pdf

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