Model Number 15 |
Device Problem
Incorrect Interpretation of Signal (1543)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/22/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Physio-control contacted the customer to request additional information on the patient.No response has been received from the customer.Physio-control will not request any patient identifying information to be in accordance with regulation (eu) 2016/679 of the european parliament and of the council.Physio-control 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 physio-control to report that the device would not recommend a shock for a rhythm that they believed to be shockable.As a result, defibrillation therapy would not be available 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 was contacted numerous times for more details, but no response appears to be forthcoming.The device has not been returned to stryker for evaluation, and no device data has been provided for review.The reported issue could not be verified and the cause of the reported issue could not be determined.
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Event Description
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A customer contacted physio-control to report that the device would not recommend a shock for a rhythm that they believed to be shockable.As a result, defibrillation therapy would not be available 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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