Catalog Number 295053-001 |
Device Problems
Device Inoperable (1663); Device Operational Issue (2914)
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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 03/23/2018 |
Event Type
malfunction
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Manufacturer Narrative
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This alleged failure mode poses a low risk to the patient because the car charger issue did not prevent the freedom driver from performing its life-sustaining functions.The freedom car charger will be returned to syncardia for evaluation.The results of the evaluation will be provided in a follow-up mdr.(b)(4).
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Event Description
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The freedom car charger is component that enables the freedom driver to be plugged into a 12v vehicle power outlet.The customer, a syncardia certified hospital, reported that the patient's freedom power adaptor indicator light would not light up green when connected to the car charger as a power source.The customer also reported confirming the experience using the backup freedom driver.
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Event Description
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The freedom car charger is component that enables the freedom driver to be plugged into a 12v vehicle power outlet.The customer, a syncardia certified hospital, reported that the patient's freedom power adaptor indicator light would not light up green when connected to the car charger as a power source.The customer also reported confirming the experience using the backup freedom driver.
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Manufacturer Narrative
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A return material authorization (rma) was issued for the return of the car charger; however, the site confirmed it did not return the car charger using the rma and instead shipped it with other equipment.Therefore, when the car charger was received at syncardia without an associated rma, it was discarded per procedure mfg-239, driver receiving and sanitation procedure.This issue will continue to be monitored and trended in the customer experience process.Syncardia has completed its evaluation of this complaint and is closing this file.(b)(4) follow-up report 1.
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Manufacturer Narrative
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A return material authorization (rma) was issued for the return of the car charger; however, the site confirmed it did not return the car charger using the rma and instead shipped it with other equipment.Therefore, when the car charger was received at syncardia without an associated rma, it was discarded per procedure mfg-239, driver receiving and sanitation procedure.This issue will continue to be monitored and trended in the customer experience process.Syncardia has completed its evaluation of this complaint and is closing this file.(b)(4) follow-up report 1.
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Event Description
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The freedom car charger is component that enables the freedom driver to be plugged into a 12v vehicle power outlet.The customer, a syncardia certified hospital, reported that the patient's freedom power adaptor indicator light would not light up green when connected to the car charger as a power source.The customer also reported confirming the experience using the backup freedom driver.
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Search Alerts/Recalls
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