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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCAR Recall
Reference Number: mdprc 095 07 12 000
Date submitted: 7/29/2012
Manufacturer:Ascom
Device Type:Monitoring, Ascom Mobile Monitoring Gateway (MMG)and Cardiomax
Description:Mobile Monitoring ,Alarm application software
Medical Device Identifier: MMG, Mobile Monitoring Gateway and Cardiomax // Models MMG FE3-D1ABAA and FE3-D1ABAB resp. Cardiomax FE3-G1ABAB
Reason of Field Safety Corrective Action: When assignments are changed for a location, the location conditions are stored in amemory cache; however, these entries are not deleted. Eventually the memory cache becomes full which results in a module reboot. During this time, no information is communicated to any display devices
Remedy Action: Ascom has resolved the anomaly, and has developed, verified, and validated a solution. Your local Ascom Wireless Solutions representative will contact you to schedule an upgrade of your MMG and/or Cardiomax. The MMG shall be updated to software version 3.02 and Cardiomax to 4.00 at the customer site.
Athorized Representative/Importer/Distributor:N/A
Report Source:NCAR
Source Ref. Number:SE-2012-07-18-026
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:No Attachments