Model Number 397002-001 |
Device Problems
Break (1069); Detachment Of Device Component (1104); Mechanical Problem (1384)
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Patient Problems
No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
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Event Date 02/07/2018 |
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 the issue was observed when the companion 2 driver was not supporting a patient.Syncardia personnel repaired the key switch in the field by removing the broken piece of key.The companion 2 driver was turned on using the driver's spare key and passed the system check procedure.The companion 2 driver remains at the site as a hospital standby driver and will be returned to syncardia no later than its next service date 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.
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Manufacturer Narrative
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The companion 2 driver remains at the site and is being used for patient support.(b)(4) follow-up report 1.
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Search Alerts/Recalls
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