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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 129 08 14 001
Date submitted: 9/10/2014
Manufacturer:GE Healthcare
Device Type:Patient Data Module (PDM) and CARESCAPE Monitor Bx50 (B850, B650, or B450)
Description:Monitors
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.
Remedy Action:- 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.
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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
Athorized Representative/Importer/Distributor:GE Healthcare
Report Source:NCMDR
Source Ref. Number:14BD9ACFEC326, 3B76E67A06217
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: GE Healthcare.pdf