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Medical Devices Sector
قطاع الأجهزة الطبية
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NCMDR Recall
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Reference Number:
mdprc 118 12 17 000
Date submitted:
12/28/2017
Manufacturer:
Edwards Lifesciences
Device Type:
ClearSight Heart Reference Sensor
Description:
Patient positioning sensor
Medical Device Identifier:
Model Number: EVHRS
All serial numbers manufactured after December 31, 2015
Reason of Field Safety Corrective Action:
The current product as well as the affiliated labeling contains an expiration date of two years. Through investigation and analysis of complaint data, we discovered that HRS units are susceptible to experiencing an “HRS Out of Range” error message in the EV1000 platform that are beyond six months from the date of manufacture. As a result, we have decided to change the expiration date to six months from the date of manufacture.
Remedy Action:
Edwards Life sciences are advising customers that they will be in contact with affected users to arrange for replacement of the device. In the interim, if users do not encounter the "HRS Out of Range" message on the EV1000 clinical platform, the HRS is functioning properly and patient monitoring is not adversely impacted.
Athorized Representative/Importer/Distributor:
Arabian Health Care Supply Co. (AHCSC)
Report Source:
NCMDR
Source Ref. Number:
3C4CCD46DE279
SFDA Comments:
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:
Edwards Lifesciences.pdf
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