Model Number 20E |
Device Problem
Failure to Sense (1559)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/16/2023 |
Event Type
Death
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Event Description
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The customer contacted stryker to report that their device repeatedly gave "connect electrodes" message when patient load was connected.In this state, the device may not be able to deliver defibrillation therapy if needed.The patient associated with the reported event did not survive.
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Manufacturer Narrative
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Stryker contacted the customer to request additional information on the patient.No response has been received from the customer.Stryker continues to investigate the reported failure and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.Stryker performed a clinical review regarding the reported issue.There is insufficient reported information to determine the device's contribution to the reported outcome.
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Event Description
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The customer contacted stryker to report that their device repeatedly gave "connect electrodes" message when patient load was connected.In this state, the device may not be able to deliver defibrillation therapy if needed.The patient associated with the reported event did not survive.
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Manufacturer Narrative
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Stryker evaluated the customer¿s device and was unable to verify or duplicate the reported issue.The device passed functional and performance testing and was returned to the customer for use.The cause of the reported issue could not be determined.
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Search Alerts/Recalls
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