Model Number 20 |
Device Problem
Energy Output Problem (1431)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/03/2013 |
Event Type
malfunction
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Event Description
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The customer contacted physio-control to report that their device had a service indicator present.There was no known patient use associated with the reported event.Upon examination of the device, physio-control observed that it would only deliver 10.1 joules of energy, regardless of the amount that had been selected.
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Manufacturer Narrative
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(b)(4).Physio-control examined the customer's device and verified the reported failure.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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Manufacturer Narrative
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Physio-control replaced the therapy pcb assembly and completed other unrelated repairs.After observing proper device operation through functional and performance testing the device was returned to the customer for use.Physio further examined the removed therapy pcb assembly and determined that the cause of the reported failure was a broken filter, designator fl29.
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Search Alerts/Recalls
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