Model Number 15 |
Device Problem
Unexpected Shutdown (4019)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/26/2021 |
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.Patient fields in which information is not provided were intentionally left blank.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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The customer contacted physio-control to report that their device powered down several times during use on a patient.In this state the device may not be able to deliver defibrillation therapy if needed.This issue is patient related; however there was no adverse event reported.
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Event Description
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The customer contacted physio-control to report that their device powered down several times during use on a patient.In this state the device may not be able to deliver defibrillation therapy if needed.This issue is patient related; however there was no adverse event reported.
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Manufacturer Narrative
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Physio-control received additional patient information from the customer.The customer provided physio-control with the available patient information.Patient fields in which information is not provided were intentionally left blank.
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Event Description
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The customer contacted physio-control to report that their device powered down several times during use on a patient.In this state the device may not be able to deliver defibrillation therapy if needed.This issue is patient related; however there was no adverse event reported.
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Manufacturer Narrative
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Physio-control evaluated the customer's device and duplicated the reported issue.Root cause is unable to be determined, however the issue may be due to a battery not being fully latched in the well after observing proper device operation through functional and performance testing, the device was returned to the customer for use.
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