Model Number 1000 |
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 09/29/2023 |
Event Type
malfunction
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Event Description
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The customer contacted stryker to report that his device was displaying the message "connect electrodes" when sufficient load was applied.As a result, defibrillation therapy would not be available, if needed.There were no adverse effects to the patient as a result of the reported event.
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Manufacturer Narrative
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Stryker contacted the customer to request additional information on the patient.The customer provided stryker with the available patient information.Patient fields in which information is not provided were intentionally left blank.A stryker service representative performed an initial evaluation of the customer¿s device and was not able to verify the reported issue.After observing the correct operation of the device through functional and performance tests, the device was subsequently returned to the customer.
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Manufacturer Narrative
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The electrodes from the reported event were not returned.The root cause was unable to be determined.
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Event Description
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The customer contacted stryker to report that his device was displaying the message "connect electrodes" when sufficient load was applied.As a result, defibrillation therapy would not be available, if needed.There were no adverse effects to the patient as a result of the reported event.
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Search Alerts/Recalls
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