Catalog Number 595000-001 |
Device Problem
Audible Prompt/Feedback Problem (4020)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/28/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The freedom driver will be returned to syncardia for evaluation.The results will be provided in a follow-up mdr.
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Event Description
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The customer, a syncardia certified distributor, reported the patient had red alarm on the driver.He was sitting and all parameters were normal at the time of the event.The driver was switched out with no patient impact.
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Manufacturer Narrative
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Device history record (dhr) review confirmed that freedom driver s/n (b)(6) was serviced and passed all functional testing prior to being released to finished goods.Alarm history data review and visual inspection of internal components confirmed the customer reported fault alarm condition.Visual inspection of external components found no abnormalities.The freedom driver passed all functional testing at incoming inspection and during investigation testing.Complaint could not be replicated.The failure investigation found no evidence of a device malfunction.Patient was switched to a backup driver without any reported adverse impact.This issue will be monitored and trended as part of the customer complaint process.Syncardia has completed its evaluation and is closing this file.If new or additional information is received in the future, syncardia will file a follow-up mdr.
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Event Description
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The customer, a syncardia certified distributor, reported the patient had red alarm on the driver.He was sitting and all parameters were normal at the time of the event.The driver was switched out with no patient impact.
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Search Alerts/Recalls
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