Catalog Number 295400-002 |
Device Problem
Material Integrity Problem (2978)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/06/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The freedom hospital ac power supply will be returned to syncardia for evaluation.The results will be provided in a follow-up mdr.Ce (b)(4).
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Event Description
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The freedom hospital ac power supply is a component that enables the freedom driver to be plugged into an external power source.The customer, a syncardia authorized distributor, reported that the freedom hospital ac power supply had a damaged connector.
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Manufacturer Narrative
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During visual inspection, damage to the connector was confirmed.Additionally, three of the four power supply rubber feet were missing and physical damage was observed at the strain relief connecting the power cord to the brick.During investigation testing, the power supply was found to be functional despite the observed damage.The observed damage did not affect the functionality of the power supply and was mostly likely due to rough handling.This issue will be monitored and trended as part of the customer experience process.Syncardia has completed its investigation and is closing this file.(b)(4) follow-up report 1.
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Search Alerts/Recalls
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