Model Number 15 |
Device Problems
Incorrect Interpretation of Signal (1543); Failure to Sense (1559)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/01/2023 |
Event Type
malfunction
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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.Patient fields in which information is not provided were intentionally left blank.Stryker will not request any patient identifying information to be in accordance with regulation (eu) (b)(4) of the european parliament and of the council.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.
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Event Description
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A customer contacted stryker to report that their device would not recognize the patient being connected.As a result, the device would not been able to deliver defibrillation therapy, if needed.There were no reports of adverse effects to the patient as a result of the reported event.
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Manufacturer Narrative
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The customer also reported that the device would not recognize a shockable rhythm.Stryker evaluated the customer's device and was unable to verify and duplicate the reported issue.After performing other unrelated repairs, proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer for use.
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Event Description
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A customer contacted stryker to report that their device would not recognize the patient being connected.As a result, the device would not been able to deliver defibrillation therapy, if needed.There were no reports of adverse effects to the patient as a result of the reported event.
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Search Alerts/Recalls
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