Model Number 15 |
Device Problem
Device Sensing Problem (2917)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/13/2021 |
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 did not recognize the paddles lead as connected during a patient event.As a result, defibrillation therapy may have been unavailable, if needed.The customer reported the patient involved in the reported event is deceased; however, the paramedics at the scene confirmed that the device use did not contribute to the outcome of the patient.
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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 replaced the device's therapy pcb and power pcb assemblies as a precaution.After observing proper device operation through functional and performance testing, the device was returned to the customer for use.Physio-control further evaluated the removed therapy pcb and power pcb assemblies.No issues were observed with either component.The cause of the reported issue could not be determined.
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Event Description
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The customer contacted physio-control to report that their device did not recognize the paddles lead as connected during a patient event.As a result, defibrillation therapy may have been unavailable, if needed.The customer reported the patient involved in the reported event is deceased; however, the paramedics at the scene confirmed that the device use did not contribute to the outcome of the patient.
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Search Alerts/Recalls
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