Model Number 397002-001 |
Device Problems
Break (1069); Appropriate Term/Code Not Available (3191)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
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Event Date 01/04/2018 |
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 although the key was broken in the key switch, the driver was able to perform its life-sustaining functions.The companion 2 driver has been returned to syncardia for evaluation.The results of the evaluation will be provided in a follow-up mdr.(b)(4).
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Event Description
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The customer, a syncardia certified hospital, reported that the key was found broken off inside the key switch of the companion 2 driver.The customer also reported that a screw driver was used to turn the key switch to the on position and the driver started up and functioned properly.The customer also reported that they chose to support the patient with the driver despite the broken key.
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Manufacturer Narrative
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The companion 2 driver was returned to syncardia for evaluation.Visual inspection of the driver revealed a broken key inside the key switch, confirming the customer-reported issue.Review of the driver's patient data file data revealed no alarms related to the customer-reported issue or indicative of a device malfunction.Although the key was broken inside the key switch, the switch was still operational and the driver passed incoming functional testing.The root cause of the broken key could not be conclusively determined.However, it is likely that the key was subjected to improper use or improper packaging during the driver's recorded site transfers.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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Event Description
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The customer, a syncardia certified hospital, reported that the key was found broken off inside the key switch of the companion 2 driver.The customer also reported that a screw driver was used to turn the key switch to the on position and the driver started up and functioned properly.The customer also reported that they chose to support the patient with the driver despite the broken key.
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Manufacturer Narrative
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Corrected data: to reflect updated information that issue was observed when companion 2 driver was not supporting a patient.(b)(4) follow-up report 2.
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Event Description
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The companion 2 driver was not supporting a patient.The customer, a syncardia certified hospital, reported that the key was found broken off inside the key switch of the companion 2 driver.
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Search Alerts/Recalls
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