Catalog Number 397003-001 |
Device Problem
Failure to Charge (1085)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/22/2016 |
Event Type
malfunction
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Manufacturer Narrative
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This alleged failure mode poses a low risk to a patient because the hospital cart was not in use with a patient when the issue was observed.The companion hospital cart 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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This syncardia companion hospital cart was not in patient use.The syncardia companion hospital cart is a large cart with wheels into which the syncardia companion 2 driver docks.It is intended for use in the hospital during the temporary total artificial heart (tah-t) implant procedure and subsequent recovery.The customer, a syncardia certified hospital, reported that a companion 2 driver did not charge while docked in the hospital cart.
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Manufacturer Narrative
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The companion hospital cart was returned to syncardia for evaluation.The customer-reported issue of the hospital cart not able to charge a companion 2 driver was confirmed.The root cause was identified as a malfunction of the dc power supply.The dc power supply was not allowing power to pass from the cart to the driver.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).
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Event Description
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This syncardia companion hospital cart was not in patient use.The syncardia companion hospital cart is a large cart with wheels into which the syncardia companion 2 driver docks.It is intended for use in the hospital during the temporary total artificial heart (tah-t) implant procedure and subsequent recovery.The customer, a syncardia certified hospital, reported that a companion 2 driver did not charge while docked in the hospital cart.
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Search Alerts/Recalls
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