Catalog Number 295600-001 |
Device Problems
Loose or Intermittent Connection (1371); Physical Property Issue (3008)
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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 12/14/2017 |
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 this issue 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.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) initial.
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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 had a loose connection when inserted in the patient's freedom driver.
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Manufacturer Narrative
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The freedom home ac power supply was returned to syncardia for evaluation.Visual inspection revealed a chip out of the corner of the power brick and a missing outer housing to the hypertronics connector at the dc end of the ac power supply.Functional testing determined that the unit could receive input power but could not output to a driver because the outer housing of the hypertonics connector was missing and it could not physically connect to the driver.The root cause of the customer-reported loose connection was determined to be the missing hypertronics connector outer housing.This issue will continue to be monitored and trended through 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 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 had a loose connection when inserted in the patient's freedom driver.
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Search Alerts/Recalls
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