BEUDAMED
    FDA Recall Terminated

    Michigan Instruments Thumper Mechanical CPR Device; Model 1007, Part number 15000.

    Recall: Z-0178-2007 · Initiated September 14, 2006

    Recall

    Recall Number
    Z-0178-2007
    Event Number
    36313
    Firm
    Michigan Instruments, Inc.
    FEI Number
    1821850
    Product Code
    DRM
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 14, 2006
    Posted
    November 14, 2006
    Terminated
    December 6, 2006
    Address
    4717 Talon Court S.E., Grand Rapids, MI, 49512-5408

    Description

    Michigan Instruments Thumper Mechanical CPR Device; Model 1007, Part number 15000.

    Reason

    Failure to initiate compressions when turned on.

    Action

    The Japanese distributor is instructed by letter dated 9/14/06 to drill a small hole in the male checked connector at the base of the column in order to allow rapid bleed off of the pressure and to give customers a revised operators manual.

    Distribution

    Japan.

    Quantity

    639