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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 016 01 13 000
Date submitted: 1/5/2013
Manufacturer:Hamilton Medical Inc
Device Type:Transport ventilator, HAMIL TON-T1
Description:Transport ventilator
Medical Device Identifier: MODELS: HAMIL TON-T1 with SW version ~ 1.1.2 SE RIAL NUMBERS: All HAMIL TON-T1
Reason of Field Safety Corrective Action: Unexpected high internal oxygen consumption of the HAMIL TON-T1 transport ventilator may cause miscalculation of the required oxygen for long time applications with limited oxygen supply.
Remedy Action: Immediate actions required by operators: Calculate the required oxygen capacity prior to transports as attached. the manufacturer Rework and provide updated HAMIL TON-T1 labeling (e.g., Operator's Manual). Develop and provide updated software with optimized internal oxygen consumption and overall oxygen consumption monitoring.
Athorized Representative/Importer/Distributor:Taleiamedical ,Riyadh (01) 4862662
Report Source:NCAR
Source Ref. Number:CH-2013-01-03-001
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Hamilton Medical Inc.pdf