BEUDAMED
    FDA Recall Terminated

    Welch Allyn PIC 50 Portable Intensive Care System Multi-Parameter Monitor/Defibrillator; a portable, 12V internal battery powered defibrillator; Manufactured by MRL Inc., A Welch Allyn Company, 1000 Asbury Drive, Buffalo Grove, Illinois 60089

    Recall: Z-1195-06 · Initiated June 30, 2006

    Recall

    Recall Number
    Z-1195-06
    Event Number
    35688
    Firm
    MRL, Inc., A Welch Allyn Company
    FEI Number
    1418729
    Product Code
    MJK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 30, 2006
    Posted
    July 8, 2006
    Terminated
    November 20, 2007
    Address
    1000 Asbury Dr, Ste 17, Buffalo Grove, IL, 60089-4551

    Description

    Welch Allyn PIC 50 Portable Intensive Care System Multi-Parameter Monitor/Defibrillator; a portable, 12V internal battery powered defibrillator; Manufactured by MRL Inc., A Welch Allyn Company, 1000 Asbury Drive, Buffalo Grove, Illinois 60089

    Reason

    The Welch Allyn PIC 50 Defibrillators may display a 'Defib Comm' or 'Pace Comm' error message on the device display during use which may result in a terminal failure of the device to analyze the patient's ECG and deliver the appropriate therapy.

    Action

    MRL sent Urgent Medical Device Recall letters dated 6/30/06 via certified mail to the direct accounts informing them of an intermittent connection between a pin and socket on a circuit board inside of the device that could result in a malfunction that prevents or unacceptably delays the delivery of a defibrillating shock, which possibly could result in failure to resuscitate the patient. The accounts were provided a list of the affected units' parts/serial numbers and requested to inspect their PIC 50 units for the affected serial numbers and return the identified units for servicing. The accounts were also instructed to respond to the notification within 5 working days if the unit has displayed the Defib Comm error, and within 30 days if it has not displayed the Defib Comm error by fax or mail. A loaner PIC 50 will then be sent to the consignee with instructions on how to return their unit for correction.

    Distribution

    Worldwide-including USA, Puerto Rico, Australia, Belgium, Canada, China, Cyprus, France, Germany, India, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Malaysia, Poland, Portugal, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Sultanate of Oman, Switzerland, United Arab Emirates, United Kingdom and Vietnam.

    Quantity

    673 units - USA, 511 units - International