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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 141 05 17 000
Date submitted: 5/25/2017
Manufacturer:Medtronic SA
Device Type:MiniMed 640G Insulin Infusion Pump..
Description:Infusion Pump
Medical Device Identifier:Models: MMT-1711, MMT-1712
Reason of Field Safety Corrective Action:Keypad buttons on the MiniMed 640G insulin pumps may become temporarily unresponsive when the atmospheric pressure around the pump increases or decreases rapidly. This would most likely happen when traveling in an airplane during take-off or landing. If this happens, in most cases a patient may not even notice because the pump will resolve this on its own. Find attached FSCA Reporting Form for more details. Required
Remedy Action:If you experience this keypad condition, and want to resolve it immediately to bolus or clear the alarm, remove the battery cap from the pump and then place it back on.
Athorized Representative/Importer/Distributor:Medtronic Saudi Arabia
Report Source:NCMDR
Source Ref. Number:87D44635141EA
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Medtronic.pdf