Stryker Lifepak 15 Monitor/Defibrillator Recall [US]


US FlagUS/Silver Spring: Stryker Lifepak 15 Monitor/Defibrillator Recall [US]Stryker, a Kalamazoo, Michigan establishment, recalls an estimated 13,003 Lifepak 15 Monitor/Defibrillator Medical Devices due to suspected operational malfunction and consequential risk of device lock-up after a defibrillation shock is delivered and subsequent failure to function, possibly leading to delay or complete failure of the device to operate in an emergency and possible injury and/or death, all serious health and safety hazards. Deaths reported.

FDA: http://ht.ly/1P0530nAsHs

Direct link: https://www.fda.gov/Safety/Recalls/ucm630455.htm

Additional information:
The US Food and Drug Administration (“FDA”) reports the following Monitor/Defibrillator Medical Devices are subject to this recall:

  • Stryker Lifepak 15 Monitor/Defibrillator

Please consult the photograph above for details of the device’s design and retail presentation.

==> No barcodes, UPCs, item numbers or other identification numbers were listed with this recall notification.

According to the FDA, Stryker is notifying certain Lifepak 15 customers of an issue that may cause the device to lock up after a defibrillation shock is delivered. The lock-up condition is defined as a blank monitor display with LED lights on, indicating power to the device, but no response in the keypad and device functions. A device in this condition has the potential to delay delivery of therapy, and this delay in therapy has the potential to result in serious injury or death.

The company is contacting customers with impacted devices to schedule the correction of their device(s), which will include an update to the firmware for a component on the System Printed Circuit Board Assembly. Stryker anticipates that all devices subject to this field action will be serviced by December 31, 2019. If a customer experiences this issue, they should contact Stryker as soon as possible at 1 800 442 1142 and selecting option 7.

Since the initial commercialization of Lifepak 15 in 2009, Stryker has become aware of 58 complaints reported globally for this issue, including six (6) events in which the patient died following a delay in therapy. In all six (6) of these cases, at least one shock was delivered prior to the device experiencing the lock-up condition. There are 13,003 devices potentially impacted by this issue and within scope of this field action.

The company is instructing customers to continue to use their Lifepak 15 Monitor/Defibrillator according to the Operating Instructions until the correction can be completed. Device Automatic Self-Tests do not identify this fault, as it occurs during defibrillation. Customers should continue to perform the daily check as described in the Operator’s Checklist, specifically, the QUIK-COMBO therapy cable check as described in the General Maintenance and Testing Section (pages 10-4 and the Lifepak 15 Monitor/Defibrillator Operator’s Checklist, number 7).

If a device exhibits the lockup condition during patient use, the steps from the General Troubleshooting Section (page 10-18) of the Lifepak 15 Monitor/Defibrillator Operating Instructions should be immediately followed:

  1. Press and hold ON until the LED turns off (approximately five (5) seconds). Then press ON to turn the device back on.
  2. If the device does not turn OFF, remove both batteries and disconnect the device from the power adapter, if applicable. Then reinsert batteries and/or, reconnect the power adapter, and press ON to turn the device back on.

Information about this notice is available at: http://www.strykeremergencycare.com/productnotices. Impacted customers will be notified by letter and will be requested to verify their device status. Customers with questions regarding this notification, please contact Stryker by calling 1-800-442-1142, option 7, from 6:00 AM to 4:00 PM, Pacific Standard Time, Monday to Friday, or by sending an e-mail to rsfa281@stryker.com or fax to 1-425-867-4948.

You can read more about this recall by visiting https://www.stryker.com/us/en/about/news/2019/stryker-launches-voluntary-field-action-for-specific-units-of-th.html

==> To see other recalls and notifications for products manufactured, marketed and/or sold by Stryker, please search for “Stryker” using the Search Box at the top of this page.

==> To see other recalls and notifications for products manufactured, marketed and/or sold under the LIFEPAK brand name, please search for “Lifepak” using the Search Box at the top of this page.

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More information about this recall:
Recalls Direct RIN: 11083-2019
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