BEUDAMED
    FDA Enforcement Class II Terminated

    Spacelabs Pediatric Flow Sensor Kit, PN: 376-0561-00. This kit is for Spacelabs Healthcare Blease 700/900 Series Ventilators. Designed specifically for the mechanical ventilation of adult and pediatric patients under general anesthesia.

    Recall: Z-1458-2015 · Reported April 29, 2015

    Enforcement

    Recall Number
    Z-1458-2015
    Event ID
    70754
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Del Mar Reynolds Medical, Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 29, 2015
    Initiation Date
    March 5, 2015
    Classification Date
    April 20, 2015
    Termination Date
    November 16, 2015
    Address
    1 2 Harforde Court John Tate Road, Business Park, Hertford, N/A, United Kingdom

    Description

    Spacelabs Pediatric Flow Sensor Kit, PN: 376-0561-00. This kit is for Spacelabs Healthcare Blease 700/900 Series Ventilators. Designed specifically for the mechanical ventilation of adult and pediatric patients under general anesthesia.

    Reason

    Reports of inaccurate low flow readings. Monitored inspiratory tidal volume (VTi) and expiratory tidal volume (Vte) measurements from the pediatric flow sensor are reporting out of specification low compared to the actual delivered volumes being administered to the patient.

    Code Info

    PN: 376-0561-00.

    Distribution

    Worldwide Distribution-US including the states of Louisiana, North Carolina, and Washington and the countries of Argentina, Brazil, China, Colombia, Ecuador, Finland, Great Britain, India, Libya, Mexico, Nicaragua, Oman, Philippines, Saudi Arabia, Slovakia, Sri Lanka, United Arab Emirates, and Vietnam.

    Quantity

    1040 units total (398 in the US and 642 international)