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 07/18/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).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 an event code is logged in the memory of their device.The event code logged in the device's 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 report of 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 an event code is logged in the memory of their device.The event code logged in the device's 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 report of patient use associated with the reported event.
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Manufacturer Narrative
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Physio-control evaluated the customer's device and verified the reported issue.Physio replaced the device's therapy pcb assembly.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 assembly and determined that the cause of the reported issue was due to a shorted diode, designator cr30.
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