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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
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ational
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enter for
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edical
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evices
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eporting
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NCAR Recall
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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
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