FDA: Six patients reportedly die due to defibrillator malfunction, Stryker recalls

The device reportedly locks up after shock

FDA: Six patients reportedly die due to defibrillator malfunction, Stryker recalls
LIFEPAK 15 (Source: strykeremergencycare.com)

(KPLC) - Stryker is voluntarily recalling specific units of LIFEPAK 15 Monitor/Defibrillators due to the possibility of the device locking up after a shock is delivered, according to the FDA.

The company noticed the issue after receiving complaints from 58 customers, says the FDA. Six patients reportedly died due to the delay in therapy.

The device’s screen reportedly turns black with the LED lights on, the FDA says. This indicates the device has power, but has no response from the keypad nor device functions.

FDA says around 13,000 devices could be affected. Customers using the device are asked to follow these instructions if the device locks up:

  • Press and hold ON until the LED turns off (~5 seconds). Then press ON to turn the device back on.
  • 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.

Customers with the impacted device are asked to schedule a device update to correct the issue, says the FDA. You can contact Stryker at 1-800-442-1142, ext. 7.

See the full report HERE.

LIFEPAK 15
LIFEPAK 15 (Source: strykeremergencycare.com)

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