MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA FREEDOM AC POWER SUPPLY

Catalog Number 295050-001

Device Problems Failure to Charge (1085); Power Problem (3010)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/01/2015

Event Type  malfunction  

Event Description

This (b)(4) a/c power supply was not in use with the patient's (b)(4) driver.The (b)(4) a/c power supply is a component that enables the (b)(4) driver and (b)(4) battery charger to be plugged into an external power source.The customer reported that the patient's freedom onboard batteries were not fully charging when placed in the (b)(4) battery charger that was connected to external wall power by the a/c power supply.There was no patient impact.

Manufacturer Narrative

This alleged failure mode poses a low risk to the patient because the issue was observed when the a/c power supply was in use with the (b)(4) battery charger and not in use with the patient's (b)(4) driver.If the a/c power supply were in use with the patient's (b)(4) driver, this alleged failure mode would not prevent the (b)(4) driver from performing its life-sustaining functions.The (b)(4) driver has a redundant power source of onboard batteries.An investigation will be conducted by syncardia.The results of the investigation will be provided in a supplemental mdr.

Manufacturer Narrative

(b)(4) follow-up report 1.

Event Description

This freedom a/c power supply was not in use with the patient's freedom driver.The freedom a/c power supply is a component that enables the freedom driver and freedom battery charger to be plugged into an external power source.The customer reported that the patient's freedom onboard batteries were not fully charging when placed in the freedom battery charger that was connected to external wall power by the a/c power supply.There was no patient impact.The freedom ac power supply was returned to syncardia for evaluation.Visual inspection of the freedom ac power supply revealed scratches on the housing, broken strain relief on the cord that connects to the power adaptor, and arcing marks on the electrical receptacles of the connector.The ac power supply did not pass functional testing.The root cause of the customer-reported issue of the ac power supply was a malfunction of the ac power supply caused by connector receptacles that were worn from arcing.Arcing occurs when power is applied to the ac power supply before the connector is connected to the battery charger.Numerous episodes of arcing will eventually burn and wear out the connector's receptacles, which cause the receptacles to not completely contact their mating connections on the battery charger, resulting in an intermittent connection.Therefore, the ac power supply could not supply power to the battery charger.This failure mode posed a low risk to the patient, because it had no effect on the ability of the patient's freedom driver to perform its life-sustaining functions.Ac power supplies are accessories to the freedom driver system.The freedom driver has a redundant power source of onboard batteries.The ac power supply was taken out of service.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.

• Brand Name: SYNCARDIA FREEDOM 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 Key: 4548251
• MDR Text Key: 5512392
• Report Number: 3003761017-2015-00073
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,health professional,use
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 02/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Catalogue Number: 295050-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 54 YR