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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 076 05 15 000
Date submitted: 5/17/2015
Manufacturer:Hamilton Medical Inc
Device Type:Hamilton Medical lnfant Flow Sensor
Description:lnfant Flow Sensor
Medical Device Identifier:
Hamilton Medical lnfant Flow Sensor, single use (1.6 m), PN 260177
Hamilton Medical lnfant Flow Sensor, single use (1.88 m), PN 155500
Hamilton Medical lnfant Flow Sensor, single use (3.1 m), PN 260179
Reason of Field Safety Corrective Action:
Investigations have shown that a volume reading discrepancy may occur under a combination of several effects:
- The application of low inspiratory flows (typically < 10 l/min) to neonatal/infant patients in open bed structures (outside an incubator)
- The use of active humidifiers
Remedy Action:
- Action required by device operators:
The operators in environments where the Hamilton Medical lnfant Flow Sensor is used in combination with Hamilton Medical ventilator must be alerted about the correct positioning of the Flow Sensor within the breathing circuit as shown in the following figure (See attached_ By placing the flow sensor at an angle of at least 45°, possible water condensation is prevented.
Should water accumulate it can optimally be removed by closed suctioning.
The instruction for use for the Hamilton Medical AG Infant Flow Sensor is included in this Field Safety Notice.
-Actions by the distributors:
Distribute this Medical Device Field Safety Notice immediately to all Operators of the Hamilton Medical ventilators.
Athorized Representative/Importer/Distributor:Taleiamedical
Report Source:NCAR
Source Ref. Number:CH-2015-05-13-037
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Hamilton Medical Inc.pdf