Model Number 595000-001 |
Device Problems
Display or Visual Feedback Problem (1184); Electrical /Electronic Property Problem (1198); Device Displays Incorrect Message (2591)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 04/03/2018 |
Event Type
malfunction
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Manufacturer Narrative
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This alleged failure mode poses a low risk to the patient because although the freedom driver exhibited a jump in beat rate and a temperature alarm, the freedom driver continued to perform its life-sustaining functions.The freedom driver 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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The customer, a syncardia certified hospital, reported that the freedom driver exhibited a jump in beat rate to 140 bpm while supporting the patient.The customer also reported that the patient was symptom free.The customer also reported that approximately one hour after the jump in beat rate, the freedom driver exhibited a temperature alarm and the patient reported that she "felt bad".The customer also reported that the patient was subsequently switched to the backup freedom driver.There was no reported adverse patient impact.
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Manufacturer Narrative
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The customer-reported temperature alarm was reproduced during investigation testing, when a temperature alarm sounded approximately three hours into the observation test run.Temperature alarms are not permanent alarms and are not recorded into the driver's alarm history, which is only designed to record permanent alarms.Visual examination of the driver's internal assemblies identified a loose black (ground) wire that had become detached from the exhaust fan connector.Detachment of the black (ground) wire from the connector rendered the exhaust fan inoperable.A malfunction of the exhaust fan (wire out of connector) was therefore confirmed as the root cause of the reported temperature alarm.There were no abnormalities in driver beat rate observed during the observation run and no indication of a device malfunction that would cause an increase in beat rate.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.(b)(4) follow-up report 1.
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Manufacturer Narrative
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The customer-reported temperature alarm was reproduced during investigation testing, when a temperature alarm sounded approximately three hours into the observation test run.Temperature alarms are not permanent alarms and are not recorded into the driver's alarm history, which is only designed to record permanent alarms.Visual examination of the driver's internal assemblies identified a loose black (ground) wire that had become detached from the exhaust fan connector.Detachment of the black (ground) wire from the connector rendered the exhaust fan inoperable.A malfunction of the exhaust fan (wire out of connector) was therefore confirmed as the root cause of the reported temperature alarm.There were no abnormalities in driver beat rate observed during the observation run and no indication of a device malfunction that would cause an increase in beat rate.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.(b)(4) follow-up report 1.
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Search Alerts/Recalls
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