Catalog Number 295600-001 |
Device Problems
Material Frayed (1262); Power Problem (3010)
|
Patient Problems
No Consequences Or Impact To Patient (2199); No Information (3190)
|
Event Date 01/09/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
This alleged failure mode poses a low risk to the patient because this issue did not prevent the freedom driver from performing its life-sustaining functions.In addition, the freedom driver has a redundant power source of onboard batteries.The freedom home ac power supply will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.
|
|
Event Description
|
The freedom home ac power supply is a component that enables the freedom driver to be plugged into an external power source.The customer, a syncardia certified hospital, reported that the freedom home ac power supply cable was frayed.
|
|
Event Description
|
The freedom home ac power supply is a component that enables the freedom driver to be plugged into an external power source.The customer, a syncardia certified hospital, reported that the freedom home ac power supply cable was frayed.
|
|
Manufacturer Narrative
|
The freedom home ac power supply was returned to syncardia for evaluation.Visual inspection found missing feet, a broken strain relief and a frayed cable at the location of the other strain relief, thus confirming the customer-reported issue.Functional inspection was not performed as the observed damage on the ac power supply was significant enough that energizing the unit could pose a safety risk.The root cause of the observed damage could not be determined, but is likely the result of rough handling.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation of this complaint and is closing this file.(b)(4) follow-up report 1.
|
|
Search Alerts/Recalls
|