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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 011 01 19 000
Date submitted: 1/9/2019
Manufacturer:Drägerwerk AG & Co. KGaA
Device Type:VentStar Disposable Breathing Circuits
Description:Breathing Circuits
Medical Device Identifier:Multiple affected codes are provided in the attached FSN.
Reason of Field Safety Corrective Action:Two cases have been reported to Draeger in which the incorrect connection of the breathing circuit resulted in the patients concerned not being connected to the anesthesia machine. The connections of the anesthesia machine and of the y-piece were short-circuited.
Consequently, the patients did not receive the expected ventilation. In one of the two cases the patient in question suffered irreversible harm. In the other case the patient experienced a temporary and reversible deterioration in condition.
Remedy Action:Customers are advised to inspect existing stock of the breathing circuits to ensure they are correctly assembled prior to use and to complete the customer acknowledgement form. The form can also be used to order a free replacement if customers find any breathing circuits that have been incorrectly pre-assembled.
Athorized Representative/Importer/Distributor:Draeger Arabia Co. Ltd.
Report Source:NCMDR
Source Ref. Number:4CE38B7B712A6
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Draegerwerk AG & Co KGaA.pdf