Malfunctioning defibrillators have been connected to at least six deaths around the world, prompting an alert from the manufacturer that more than 13,000 units need an update.
Some LIFEPAK 15 Monitor/Defibrillators have been reported to lock up after a shock is delivered, which can delay delivery of the next potentially life-saving shock.
Since the initial commercialization of LIFEPAK 15 in 2009, the manfacturer, Stryker, has become aware of 58 complaints reported globally for this issue, including six events in which the patient died after a delay in therapy. In all six of cases, at least one shock was delivered before the device experienced the lock-up condition.
Stryker announced Feb. 1 that 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.
There are 13,003 devices potentially impacted by this issue and within scope of this field action, Stryker said.
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 said.
Stryker anticipates that all devices that need an update will be serviced by Dec. 31, 2019.
If a customer experiences this issue, they should contact Stryker as soon as possible at 1-800-442-1142 and select option 7.
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 the fault, because 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:
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 can contact Stryker by calling 1-800-442-1142, option 7, from 6 a.m. to 4 p.m. (Pacific) Monday through Friday, or by email to firstname.lastname@example.org or fax to 1-425-867-4948.
In addition to contacting Stryker, any potential quality problems or adverse reactions or events associated with the use of a product from Stryker may be reported to the U.S. Food and Drug Administration’s MedWatch Safety Information and Adverse Event Reporting Program online at https://www.fda.gov/safety/medwatch/, by phone 1-800-332-1088 or fax 1-800-FDA-0178.