Catalog Number 295600-001 |
Device Problem
Mechanical Problem (1384)
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Patient Problems
No Consequences Or Impact To Patient (2199); Patient Problem/Medical Problem (2688)
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Event Date 09/05/2019 |
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 reported issue did not prevent the freedom driver from performing its life-sustaining functions.In addition, the freedom driver has a redundant power source of multiple onboard batteries.The freedom home ac power supply will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.(b)(4).
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Event Description
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The freedom home ac power supply is a component that enables the freedom driver to be plugged into an external power source.The customer, a syncardia certified hospital, reported that the freedom driver home ac power supply had exposed wires connected to the power supply brick while supporting the patient.There was no reported adverse patient impact.
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Manufacturer Narrative
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Visual inspection confirmed the customer-reported issue as the bend relief was found to be damaged with exposed wiring.It cannot be conclusively determined what caused the damaged bend relief, but it is likely the damage was caused by an excessive amount of tension being applied to the power source, toward the plug end.Despite the observed damage, the ac power supply conformed to all functional testing criteria.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.Ce 4959 follow-up report 1.
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Search Alerts/Recalls
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