BEUDAMED
    FDA Recall Terminated

    CARESCAPE Patient Data Module (PDM) v2.6 software used with CARESCAPE Monitors B850, B650, and B450 v2.0.7 or earlier software The PDM is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients during non-transport/bedside and transport patient care episodes. Physiological parameter data acquired by the PDM includes EGG, invasive blood pressure, non-invasive blood pressure, pulse oximetry, temperature, cardiac output and respiration. This device acquires, processes and stores information for all aforementioned parameters and transmits this information to a transport or bedside central processing unit for viewing and alarm surveillance purposes.

    Recall: Z-0202-2018 · Initiated July 13, 2017

    Recall

    Recall Number
    Z-0202-2018
    Event Number
    77818
    Firm
    GE Medical Systems Information Technologies, Inc.
    FEI Number
    2124823
    Product Code
    MHX
    Status
    Terminated
    Root Cause
    Software Design Change
    Initiated
    July 13, 2017
    Terminated
    April 1, 2021
    Address
    8200 W Tower Ave, Milwaukee, WI, 53223-3219

    Description

    CARESCAPE Patient Data Module (PDM) v2.6 software used with CARESCAPE Monitors B850, B650, and B450 v2.0.7 or earlier software The PDM is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients during non-transport/bedside and transport patient care episodes. Physiological parameter data acquired by the PDM includes EGG, invasive blood pressure, non-invasive blood pressure, pulse oximetry, temperature, cardiac output and respiration. This device acquires, processes and stores information for all aforementioned parameters and transmits this information to a transport or bedside central processing unit for viewing and alarm surveillance purposes.

    Reason

    Device does not produce a visual or audible impedance respiration APN alarm when an impedance respiration apnea event occurs.

    Action

    GE Healthcare sent an Urgent Medical Device Correction letter dated July 12, 2017, to all affected consignees via certified mail. Consignees were advised to enable "Resp Rate (Impedance)" alarms and set the low limits to the factory defaults (NICU: 20/minute; Adult ICU: 5/minute). Consignees were also advised to enable audible alarms under Alarm Priorities for RR (Impedance) high/low. GE will provide a correction free of charge once it is available. GE will contact consignees to arrange device corrections. Consignees were instructed to call 1-800-558-7044 or a local representative with any questions pertaining to this recall.

    Distribution

    Worldwide Distribution - US including NY, WI; Foreign: Australia, France, Germany.

    Quantity

    1,196 (1,176 US; 20 OUS)