Catalog Number 9058 |
Device Problem
Intermittent Loss of Power (4016)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/26/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
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Event Description
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It was reported that the driver appeared to run out of battery however the indicator light had not turned red prior to this.It was green prior to the driver stopping working.There was no patient injury.
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Manufacturer Narrative
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(b)(4).The dhr file is not available for review in the us.Ez-io driver 9058 (sn (b)(4)) was never returned to teleflex for investigation purposes.The root cause cannot be established.The complaint cannot be confirmed.Several sections of the ifu will be referenced as part of this investigation report.The ifu states, "as with any emergency medical device carrying a backup is strongly advised protocol", "ez-io power driver led with blink red when the trigger is activated and has only 10% of battery life remaining", and "purchase and replace the ez-io power driver when the red led begins blinking".A review of the certificate of conformance found that the driver passed all the release criteria.The device was released in 07/2009 and is approximately 9 years old.The complaint sample was never returned to teleflex for investigation purposes.The root cause cannot be established.The complaint cannot be confirmed.No corrective/preventative actions will be assigned.No further action required.
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Event Description
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It was reported that the driver appeared to run out of battery however the indicator light had not turned red prior to this.It was green prior to the driver stopping working.There was no patient injury.
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Search Alerts/Recalls
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