Catalog Number 293001-001 |
Device Problems
Battery Problem (2885); Communication or Transmission Problem (2896)
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Patient Problems
No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
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Event Date 04/23/2018 |
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 external battery was not supporting a patient.The companion external battery 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 companion external battery was not supporting a patient.The supplier, a syncardia authorized warehouse, reported that the companion external battery was not recognized when inserted into a companion 2 driver.The supplier also reported that the external battery was left in a companion 2 driver for over 4 days and it did not charge.
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Manufacturer Narrative
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Visual inspection and system management (smbus) data review revealed no damage or abnormalities.The companion external battery passed all functional testing requirements including the required charge/discharge test.The battery performed as intended with no evidence of a device malfunction.Therefore, the root cause of the customer-reported inability to charge could not be determined.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation and is closing this file.Ce4287 follow-up report 1.
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Search Alerts/Recalls
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