Catalog Number 295600-001 |
Device Problems
Electrical /Electronic Property Problem (1198); Mechanical Problem (1384)
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Patient Problems
No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/29/2020 |
Event Type
malfunction
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Manufacturer Narrative
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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.(b)(4).
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Event Description
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The freedom home ac power supply is a component that enables the freedom driver to be plugged into an external power source.The freedom home ac power supply was not supporting a patient.The customer, a syncardia certified hospital, reported that the freedom home ac power supply had a damaged cord.
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Manufacturer Narrative
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Visual inspection of the power supply revealed torn black outer insulation on the ac line cord.The freedom home ac power supply was tested with a known functioning freedom driver and the driver powered up successfully.This confirmed that the damage was limited to the insulation and not the wires.The root cause of this damage could not be determined but may be due to mishandling, or wear and tear of the product.This issue will be monitored and trended as part of the customer experience process.Syncardia has completed its investigation and is closing this file.(b)(4) follow-up report 1.
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Search Alerts/Recalls
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