Model Number 20E |
Device Problem
Inappropriate/Inadequate Shock/Stimulation (1574)
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Patient Problem
No Patient Involvement (2645)
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Event Date 06/14/2018 |
Event Type
malfunction
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Manufacturer Narrative
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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 the 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.There was no patient use associated with the reported event.
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Manufacturer Narrative
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Physio-control has made multiple attempted to contact the customer to obtain the status of their device.No response has been received from the customer.This device was not returned to physio-control for evaluation.The cause of the reported issue could not be determined.Device not evaluated by manufacturer.
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Event Description
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The customer contacted physio-control to report that the 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.There was no patient use associated with the reported event.
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Search Alerts/Recalls
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