Model Number 15 |
Device Problem
Inappropriate/Inadequate Shock/Stimulation (1574)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/07/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Physio-control evaluated the customer's device and verified the reported issue.Physio-control also observed that the device was delivering monophasic energy rather than biphasic energy.The energy delivered by the device was also at a lower energy level than what was selected.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 a non-critical issue with their device.There was no patient use associated with the reported event.Upon evaluation of the customer's device, physio found that a service indicator is present and an event code is logged in the memory of their device.The event code logged in its memory is indicative of a device failure that could result in a partial loss of defibrillator output energy due to a loss of the negative portion of the biphasic output waveform, resulting in a monophasic shock.Additionally, the defibrillator output energy may be reduced by up to approximately 20% from the selected energy level.As a result, the wrong defibrillation therapy would be delivered, if it were necessary.
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Manufacturer Narrative
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Physio-control replaced the device's bi-phasic pcb assembly to resolve the reported issue.Further evaluation of the removed bi-phasic pcb assembly determined that the cause of the reported issue was shorted transistors q5 and q6.
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Event Description
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The customer contacted physio-control to report a non-critical issue with their device.There was no patient use associated with the reported event.Upon evaluation of the customer's device, physio found that a service indicator is present and an event code is logged in the memory of their device.The event code logged in its memory is indicative of a device failure that could result in a partial loss of defibrillator output energy due to a loss of the negative portion of the biphasic output waveform, resulting in a monophasic shock.Additionally, the defibrillator output energy may be reduced by up to approximately 20% from the selected energy level.As a result, the wrong defibrillation therapy would be delivered, if it were necessary.
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Search Alerts/Recalls
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