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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA FREEDOM HOSPITAL AC POWER SUPPLY
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SYNCARDIA SYSTEMS, INC. SYNCARDIA FREEDOM HOSPITAL AC POWER SUPPLY Back to Search Results
Catalog Number 295400-002
Device Problems Electrical /Electronic Property Problem (1198); Overheating of Device (1437); Temperature Problem (3022)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/16/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
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 reported that the freedom hospital ac power supply overheats when plugged into any freedom driver or freedom battery charger.The customer also reported that the patient was provided with a replacement home ac power supply.There was no reported adverse patient impact.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.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.
 
Manufacturer Narrative
(b)(4).
 
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 reported that the freedom hospital ac power supply overheated when plugged into any freedom driver or freedom battery charger.The customer also reported that the patient was provided with a replacement home ac power supply.There was no reported adverse patient impact.The hospital ac power supply was returned to syncardia for evaluation.Visual inspection revealed that the hypertronics connector cover was cracked.The cracked connector cover appeared to have had a repair attempt, as adhesive of unknown origin was observed on and near the crack.Testing of the hospital ac power supply confirmed the reported issue that the temperature of the hypertronics connector was elevated.The hypertronics connector was disassembled and inspected.It was observed that the power wires were fastened to the pin receptacles by a crimp process and that the wires had been tinned before crimping.The root cause for the elevated temperature was likely related to wire tinning prior to crimping.Despite the elevated connector temperature, the ac power supply provided the proper output voltage to a freedom driver.The hospital ac power supply will be returned to the supplier for additional evaluation and corrective action.This failure mode poses a low risk to the patient because it did not prevent the freedom driver from performing its life-sustaining functions.The freedom driver has redundant power sources, including multiple rechargeable onboard batteries and a car charger, and patients are provided with multiple ac power supplies.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.
 
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Brand Name
SYNCARDIA FREEDOM HOSPITAL AC POWER SUPPLY
Type of Device
AC POWER SUPPLY
Manufacturer (Section D)
SYNCARDIA SYSTEMS, INC.
1992 e. silverlake road
tucson AZ 85713
Manufacturer Contact
carole marcot
1992 e. silverlake road
tucson, AZ 85713
5205451234
MDR Report Key5749123
MDR Text Key48925546
Report Number3003761017-2016-00248
Device Sequence Number1
Product Code LOZ
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
P030011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation Other Health Care Professional
Remedial Action Replace
Type of Report Initial,Followup
Report Date 06/16/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number295400-002
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/24/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/18/2016
Was Device Evaluated by Manufacturer? Yes
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 Age56 YR
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