Model Number 20 |
Device Problem
Device Inoperable (1663)
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Patient Problem
No Patient Involvement (2645)
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Event Date 08/04/2014 |
Event Type
malfunction
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Manufacturer Narrative
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Physio-control further examined the removed user interface (ui) pcb assembly and determined that the cause of the reported issue was an integrated circuit (ic) chip, designator u2.Both the system controller (sc) and patient parameters pcb assemblies were also examined and no failures were observed.
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Event Description
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The customer contacted physio-control to report that their device has a white display.A white display is indicative of a device lock up which would prevent the unit from being able to provide defibrillation if it were necessary.There was no patient use associated with the reported event.
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Manufacturer Narrative
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(b)(4).Physio-control examined the customer's device and verified the reported issue.Physio then replaced the system controller (sc) pcb, the user interface (ui) pcb and the patient parameters (pp) pcb assemblies, as well as completed other unrelated repairs.After observing proper device operation through functional and performance testing the unit was returned to the customer for use.
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Search Alerts/Recalls
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