Model Number 20 |
Device Problem
Device Inoperable (1663)
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Patient Problem
No Patient Involvement (2645)
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Event Date 05/18/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).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 would not complete the boot-up process in order to power on.As a result, defibrillation would not have been possible if it were necessary.There was no 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 intermittently.Physio replaced the system controller (sc) pcb assembly to resolve the reported issue and then completed other, unrelated, repairs.After observing proper device operation through functional and performance testing the unit was returned to the customer for use.Physio-control further evaluated the removed sc pcb assembly and confirmed it was the cause of the reported intermittent issue; however, further component level cause could not be determined.
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Event Description
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The customer contacted physio-control to report that their device would not complete the boot-up process in order to power on.As a result, defibrillation would not have been possible if it were necessary.There was no patient use associated with the reported event.
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Search Alerts/Recalls
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