Model Number 15 |
Device Problem
Inappropriate or Unexpected Reset (2959)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/29/2021 |
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.The customer provided physio-control with all the available patient information.Patient fields in which information was 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 repeatedly powered itself off and back on during a patient event.There were no reports of any adverse effects to the patient as a result of the reported issue.
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Event Description
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The customer contacted physio-control to report that their device repeatedly powered itself off and back on during a patient event.There were no reports of any adverse effects to the patient as a result of the reported issue.
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Manufacturer Narrative
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Physio-control evaluated the customer's device and was unable to duplicate the reported issue.Physio downloaded the device's electronic records from the event for review and was able to verify the reported issue.After completing other unrelated repairs, proper device operation was observed through functional and performance testing.The device 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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