A medical equipment company is taking action to fix a problem with defibrillators that could cause potentially fatal problems.
Stryker has announced voluntary field action on specific units of the LIFEPAK 15 monitor / defibrillator.
“The company is advising some LIFEPAK 15 customers of a problem that may cause the device to freeze after delivering a defibrillation shock,” Stryker said in the announcement.
“Lockout condition is defined as a blank monitor screen 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 the delivery of therapy, and any delay in treatment can result in serious injury or death. “
Stryker said he was aware of 58 complaints reported worldwide for the problem, including “six events in which the patient died as a result of delayed treatment.”
There are 13,003 devices potentially affected by this issue.
The company contacts customers whose devices are impacted to plan the remediation.
In the meantime, Stryker is asking customers to continue using their devices according to the operating instructions until the fix is complete.
They add :
If a device exhibits a blocked condition during patient use, the steps in the General Troubleshooting (page 10-18) section of the LIFEPAK 15 monitor / defibrillator instructions for use should be followed immediately:
Press and hold until the LED turns off (approximately 5 seconds). Then press ON to turn the device back on.
If the device does not turn off, remove both batteries and unplug the device from the AC adapter, if applicable. Then reinsert the batteries and / or reconnect the AC adapter and press ON to turn the device back on.
Customers with questions regarding this notification are encouraged to contact Stryker by calling 1-800-442-1142, option 7 6:00 a.m. to 4:00 p.m. Pacific Monday through Friday, or by email at email@example.com.
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