Model Number 595000-001 |
Device Problem
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 10/31/2017 |
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 fault alarms, it 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) initial.
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Event Description
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The customer, a syncardia authorized distributor, reported that the freedom driver exhibited fault alarms while supporting the patient.The customer also reported that the patient switched between his primary and backup freedom drivers multiple times.There was no reported adverse patient impact.
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Manufacturer Narrative
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The freedom driver was returned to syncardia for evaluation.Visual inspection of the driver revealed minor damage in the form of split housings and a fractured bottom left housing boss with raised insert, which is typically caused by an impact shock.The alarm history was reviewed and revealed an alarm code 'mpu regulator 1 too low' which is likely an alarm experienced by the customer.It can be produced as a result of an impact shock or sudden movement that causes an onboard battery that is not fully latched in place to have an intermittent electrical connection.The driver passed all incoming functional test requirements as well as a battery exchange test.The driver performed as intended with no evidence of a device malfunction.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evalaution of this complaint and is closing this file.Ce 4022 follow-up report 1.
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Event Description
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The customer, a syncardia authorized distributor, reported that the freedom driver exhibited fault alarms while supporting the patient.The customer also reported that the patient switched between his primary and backup freedom drivers multiple times.There was no reported adverse patient impact.
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Search Alerts/Recalls
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