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Medical Devices Sector
قطاع الأجهزة الطبية
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
mdprc 129 08 14 001
Patient Data Module (PDM) and CARESCAPE Monitor Bx50 (B850, B650, or B450)
Medical Device Identifier:
The issue can occur with all versions of PDM software v2.2 or lower.
Reason of Field Safety Corrective Action:
If the PDM is quickly disconnected and reconnected (a less than 10 second cycle) from a Carescape Bx50 monitor following a “Patient Discharge” or during active monitoring, the ECG waveform and its associated waveform parameters could be analyzed incorrectly.
- To prevent the occurrence of the issues identified above, when physically disconnecting the PDM from the CARESCAPETM Monitor Bx50 users should wait a minimum of 10 seconds before reconnecting. - GE Healthcare will provide a correction at no charge once it is available.
NCMDR update action :
corrective action will be deployed until April 2015. Corrective & Preventive actions:
1. Correction will be releasing the FMI kit (36107) to the field
2. The Corrective action will be releasing the PDM v2.3
Source Ref. Number:
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Copyright © 2008 Saudi Food and Drug Authority. All rights reserved.