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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 027 07 11 000
Date submitted: 7/9/2011
Manufacturer:Philips Healthcare
Device Type:IntelliVue Clinical Information Portfolio
Description:Information Systems, Data Management
Medical Device Identifier:865047 IntelliVue Clinical Information Portfolio Release D.03 , 865209 IntelliVue Clinical Information Portfolio Release E.00 and E.01, 865300 IntelliVue Clinical Information Portfolio NICU Link.
Reason of Field Safety Corrective Action:Charting the administration of medications after the scheduled time and then changing the schedule time may lead to the generation of extra pending interventions in error. A patient may receive interventions or additional medication doses that are not intended.
Remedy Action:Follow the instructions for use for the device, which includes the directions to: Always use the medication administration record (MAR) in determining patient care. Always review orders and pending administrations in the MAR after any changes to an order are stored. Philips is developing a software upgrade to address this problem in the short term. This upgrade is available immediately.
Athorized Representative/Importer/Distributor:Al-Faisaliah Medical System, Riyadh, (01) 2119999
Report Source:NCMDR
Source Ref. Number:48B37AD5A12EB
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Philips Healthcare (2) - FSN.pdf