BEUDAMED
    FDA Recall Terminated

    Hard shell carry case for the LIFEPAK 500 AED.

    Recall: Z-0004-06 · Initiated July 12, 2005

    Recall

    Recall Number
    Z-0004-06
    Event Number
    32642
    Firm
    Medtronic Emergency Response Systems, Inc.
    FEI Number
    3015876
    Product Code
    MKJ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    July 12, 2005
    Posted
    October 4, 2005
    Terminated
    June 26, 2006
    Address
    11811 Willows Rd Ne, Redmond, WA, 98052-2003

    Description

    Hard shell carry case for the LIFEPAK 500 AED.

    Reason

    Some hard shell carry case for LIFEPAK 500 and LIFEPAK CR Plus automated external defibrillators may have blocked pressure vent which may make it difficult to open the case after a sudden decrease in altitude (such as in aircraft landng or mountain descent).

    Action

    On 7/12/05 the firm issued a letter to customers instructing the customers to inspect the cases for blocked vent. If the customer noted that the vent was blocked, to contact the firm for a replacement case. The firm provided response cards for the customers to return stating they had inspected their units.

    Distribution

    Cases were distributed nationwide and internationally.

    Quantity

    4608 cases