Model Number 295025-001 |
Device Problems
Failure to Charge (1085); Charging Problem (2892)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/13/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The freedom onboard battery 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 customer, a syncardia certified hospital, reported that the patient's freedom onboard battery was unable to charge.There was no reported adverse patient impact.
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Manufacturer Narrative
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The cause for the customer-reported issue of the freedom onboard battery unable to charge is that the battery exhibited a permanent fault and was permanently disabled by its internal safety monitor.Since no system management (smbus) communications could be established, analysis of the permanent fault could not be performed and root cause could not be conclusively determined.Syncardia has a corrective and preventive action (capa) to address the inability of the user to detect when a freedom onboard battery is disabled.Syncardia has completed its investigation and is closing this file.Ce 5344 follow-up report 1.
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Search Alerts/Recalls
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