Model Number 20 |
Device Problem
Inappropriate/Inadequate Shock/Stimulation (1574)
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Patient Problem
No Patient Involvement (2645)
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Event Date 02/10/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Physio-control performed an initial evaluation of the customer¿s device and verified the reported issue.Physio also observed that the device delivered a monophasic shock and displayed, "abnormal energy delivery".Physio-control continues to investigate the reported issue 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 logged a critical event code.The event code is indicative of a device issue that could result in a partial loss of defibrillator output energy due to a loss of the negative or positive portion of the biphasic output waveform.The defibrillator output energy could be reduced by up to approximately 20% from the selected energy level.There was no patient use associated with the reported event.
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Event Description
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The customer contacted physio-control to report that their device logged a critical event code.The event code is indicative of a device issue that could result in a partial loss of defibrillator output energy due to a loss of the negative or positive portion of the biphasic output waveform.The defibrillator output energy could be reduced by up to approximately 20% from the selected energy level.There was no patient use associated with the reported event.
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Manufacturer Narrative
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Physio-control sent the customer a quote for repair, however the customer declined to have their device repaired.The customer's device was returned to the customer unrepaired.The cause of the reported issue could not be conclusively determined.
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Search Alerts/Recalls
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