Catalog Number 295070-001 |
Device Problems
Device Operates Differently Than Expected (2913); Improper Device Output (2953)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 05/22/2015 |
Event Type
malfunction
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Event Description
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The customer reported that the freedom power adaptor exhibited a green blinking light instead of a solid green light when the freedom driver was connected to wall power.The patient subsequently switched the freedom power adaptor to the backup freedom power adaptor.There was no reported adverse patient impact.This alleged failure mode poses a low risk to the patient because it did not prevent the freedom driver from performing its life-sustaining functions.In addition, the freedom driver has a redundant power source of onboard batteries.
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Manufacturer Narrative
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The freedom power adaptor will be returned to syncardia for evaluation.The results of the investigation will be provided in a supplemental mdr.
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Manufacturer Narrative
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(b)(4) follow-up report 1.
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Event Description
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The customer reported that the freedom power adaptor exhibited a green blinking light instead of a solid green light when the freedom driver was connected to wall power.The patient subsequently switched the freedom power adaptor to the backup freedom power adaptor.There was no reported adverse patient impact.The freedom power adaptor was returned to syncardia for evaluation.The visual inspection of the power adaptor performed investigation revealed no abnormalities or anomalies.The functional evaluation of freedom power adaptor s/n 1066 confirmed the blinking of the green indicator light, as reported by the customer.The root cause was determined to be an increase in voltage present at resistor r25, which is a direct result of capacitor c31 degradation.The blinking of the green led is not an indication in the power adaptor's ability to power the freedom driver or charge the batteries in the driver.This failure mode poses a low patient risk because the freedom power adaptor remained functional and would not prevent the freedom driver from performing its life-sustaining functions.In addition, the freedom driver is equipped with redundant power sources, including multiple rechargeable freedom onboard batteries and an external battery charger.Power adaptor s/n (b)(4) was taken out of service.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation of this complaint and is closing this file.
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Search Alerts/Recalls
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