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 07/01/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Physio control evaluated the customers device and verified the reported issue.Physio replaced the device's therapy pcb assembly to resolve the reported issue.After completing other unrelated repairs, proper device operation was observed through functional and performance testing.The device was returned to the customer for use.
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Event Description
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The customer contacted physio-control to report that an event code was logged in the memory of their device.The event code logged in its memory is indicative of a device failure that could result in an inappropriate monophasic shock at a reduced energy level.There was no patient use associated with the reported event.
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Manufacturer Narrative
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Physio-control further evaluated the removed therapy pcb assembly and a short circuit at diode designator cr21 and cr22 was determined to be the cause of the reported issue.
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Event Description
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The customer contacted physio-control to report that an event code was logged in the memory of their device.The event code logged in its memory is indicative of a device failure that could result in an inappropriate monophasic shock at a reduced energy level.There was no patient use associated with the reported event.
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Search Alerts/Recalls
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