BEUDAMED
    FDA Recall Terminated

    Philips HeartStart MRx devices in use with the M3539A AC Power Module: M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9

    Recall: Z-1923-2019 · Initiated June 7, 2019

    Recall

    Recall Number
    Z-1923-2019
    Event Number
    82750
    Firm
    Philips North America, LLC
    FEI Number
    1218950
    Product Code
    MKJ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    June 7, 2019
    Posted
    July 5, 2019
    Terminated
    May 8, 2020
    Address
    3000 Minuteman Rd, Andover, MA, 01810-1032

    Description

    Philips HeartStart MRx devices in use with the M3539A AC Power Module: M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9

    Reason

    The AC power module may fail at a higher than expected rate. If a fully charged battery is not properly installed, the HeartStart MRx may lose all power and fail to operate. Interruption of monitoring and failure or delay in the delivery of a shock or pacing can occur. A faulty AC Power Module may also fail to charge the battery.

    Action

    On June 7, 2019, the firm mailed Urgent Medical Device Correction letters to customers, informing them that the AC Power Module may fail, which may lead to an interruption of monitoring or a delay in the delivery of a shock or pacing therapy. A failed AC Power Module also will not charge the battery. Customers were asked to take the following actions: 1. Per the Instructions for Use (IFU), the HeartStart MRx Monitor/Defibrillator can be powered by either a Lithium Ion battery or AC mains power (using the M3539A AC Power Module). However, a charged battery should always be installed in the device, whether or not AC mains power is available at the point of care. It is also important to keep your batteries charged. 2. Verify that the AC Power Module is functioning properly: a. With the device is plugged into AC mains power, assure that the External Power Indicator on the MRx display is green, as shown in Fig. 1. b. Verify that the battery is charging or charged by checking the Battery Charge Level Indicators shown in Fig. 2 below, as a faulty AC Power Module may fail to charge the battery. 3. Verify your MRx does not show a red X nor is it emitting a periodic audio chirp as this could be an indicator that there is no battery in the unit or that the AC Power Module may have failed, and the battery charge has dropped below 20%. 4. If you identify a failed AC Power Module using the criteria above, please contact Philips for a replacement. 5. To acknowledge receipt of this notification, please complete and fax the Customer Reply Form to: +1.877.499.7223 or email to [email protected]. The firm will provide a replacement for failed AC power modules to the customer at no charge. If you need further information or support concerning this notification, please contact your local Philips representative or call the firm at 1-800-722-9377.

    Distribution

    Nationwide domestic distribution. Worldwide distribution.

    Quantity

    97,794 Units