Catalog Number 295600-001 |
Device Problem
Mechanical Problem (1384)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/25/2019 |
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 home ac power supply was not functioning properly while supporting a patient.There was no reported adverse patient impact.
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Manufacturer Narrative
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Visual inspection of the power supply revealed a missing rubber foot, physical damage to the ac power cable, and a socket out of the correct position in the dc power connector.During investigation testing, a reliable electrical connection from the power supply to the power adaptor was not achieved due to the damage observed during the visual inspection.The customer-reported issue of the power supply not functioning properly was confirmed during the investigation.The root cause was determined to be a pushed in ground pin on the dc connector.It cannot be conclusively determined what caused this damage, but it is likely from rough handling.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.(b)(4) follow-up report 1.
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Search Alerts/Recalls
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