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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA FREEDOM HOSPITAL AC POWER SUPPLY
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SYNCARDIA SYSTEMS, LLC SYNCARDIA FREEDOM HOSPITAL AC POWER SUPPLY Back to Search Results
Catalog Number 295400-001
Device Problem Power Problem (3010)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 09/07/2017
Event Type  malfunction  
Manufacturer Narrative
This alleged failure mode poses a low risk to the patient because it did not prevent the freedom driver from performing its life-sustaining functions.Additionally, the freedom driver has a redundant power source of onboard batteries.The freedom hospital ac power supply has been returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.(b)(4) initial.
 
Event Description
The freedom hospital 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 hospital ac power supply was no longer providing power while supporting a patient.The customer also reported that the patient was provided a new freedom ac power supply.There was no reported adverse patient impact.
 
Manufacturer Narrative
The freedom hospital ac power supply was returned to syncardia for evaluation.Visual inspection of the freedom hospital ac power supply's external components revealed a chip in the transformer housing near a corner and missing rubber feet.Investigational testing confirmed the customer-reported issue.The ac power supply failed to light its own green status indicator led and provided no dc output at either open circuit or with a freedom driver being used as a load.Visual internal inspection confirmed that the ac power supply was not functional because one of component l3's (inductor) leads of the circuit inside the transformer housing was detached from the board at the solder weld.The root cause of the damage to the internal main printed circuit board of the power supply is unknown based on the information provided by the customer; however, the damage to l3 is likely the result of a drop or other rough handling, which is also indicated by the damaged corner to the transformer housing.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.
 
Event Description
The freedom hospital 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 hospital ac power supply was no longer providing power while supporting a patient.The customer also reported that the patient was provided a new freedom ac power supply.There was no reported adverse patient impact.
 
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Brand Name
SYNCARDIA FREEDOM HOSPITAL AC POWER SUPPLY
Type of Device
HOSPITAL AC POWER SUPPLY
Manufacturer (Section D)
SYNCARDIA SYSTEMS, LLC
1992 e. silverlake road
tucson AZ 85713
Manufacturer Contact
michael garippa
1992 e. silverlake road
tucson, AZ 85713
5205451234
MDR Report Key6907590
MDR Text Key88167708
Report Number3003761017-2017-00175
Device Sequence Number1
Product Code LOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Remedial Action Replace
Type of Report Initial,Followup
Report Date 09/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number295400-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/20/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/07/2017
Initial Date FDA Received10/02/2017
Supplement Dates Manufacturer Received10/23/2017
Supplement Dates FDA Received11/03/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/20/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Age61 YR
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