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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 295400-002
Device Problems Break (1069); Physical Property Issue (3008)
Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Event Date 09/22/2017
Event Type  malfunction  
Manufacturer Narrative
This alleged failure mode poses a low risk to the patient because patients are provided with a backup ac power supply, and the freedom driver has a redundant power source of onboard batteries.The freedom hospital 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) 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 authorized distributor, reported that the freedom hospital ac power supply had a broken connector.The customer also reported the patient was provided a replacement 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 investigation of the power supply revealed no damage or abnormalities.Functional investigation of the unit did not identify any malfunctions or abnormalities.The freedom hospital ac power supply 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 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 authorized distributor, reported that the freedom hospital ac power supply had a broken connector.The customer also reported the patient was provided a replacement freedom ac power supply.There was no reported adverse patient impact.
 
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 authorized distributor, reported that the freedom hospital ac power supply had a broken connector.The customer also reported the patient was provided a replacement 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 investigation of the power supply revealed no damage or abnormalities.Functional investigation of the unit did not identify any malfunctions or abnormalities.The freedom hospital ac power supply 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 evaluation of this complaint and is closing this file.(b)(4) follow-up report 1.
 
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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
MDR Report Key7214954
MDR Text Key98423963
Report Number3003761017-2018-00033
Device Sequence Number1
Product Code LOZ
Combination Product (y/n)N
PMA/PMN Number
P030011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Remedial Action Replace
Type of Report Initial,Followup
Report Date 09/22/2017
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 Lay User/Patient
Device Catalogue Number295400-002
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/15/2018
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/22/2017
Initial Date FDA Received01/24/2018
Supplement Dates Manufacturer Received06/08/2018
Supplement Dates FDA Received06/13/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age48 YR
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