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

Catalog Number 295050-001

Device Problems Connection Problem (2900); Power Problem (3010)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 02/12/2015

Event Type  malfunction  

Event Description

This (b)(4) a/c power supply was not in patient use.The (b)(4) a/c power supply is a component that enables the (b)(4) driver to be plugged into an external power source.The customer reported that it was difficult to connect the (b)(4) a/c power supply to the (b)(4) power adaptor during a system check.This alleged failure more poses a low risk to a patient because the issue was observed when the (b)(4) a/c power supply was not in patient use.In addition, the (b)(4) driver has a redundant power source of onboard batteries.The (b)(4) a/c power supply will be returned to syncardia for evaluation.The results of the investigation will provided in a supplemental mdr.

Manufacturer Narrative

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

Event Description

This freedom a/c power supply was not in patient use.The freedom a/c power supply is a component that enables the freedom driver to be plugged into an external power source.The customer reported that it was difficult to connect the freedom a/c power supply to the freedom power adaptor during a system check.The freedom ac power supply was returned to syncardia for evaluation.Visual inspection of the freedom ac power supply revealed that the cable connector cover was installed in the incorrect orientation and there was a crack in the connector cover.The connector cover key tab was not aligned with the connector key slot, which prevented the ac power supply from connecting to the power adaptor properly.This is the root cause of the customer-reported ac power supply inability to provide power to a freedom power adaptor.The crack in the ac power supply connector cover was most likely the result of the user trying to force the connector into the power adaptor's receptacle with the connector cover in the incorrect orientation.This failure mode poses a low risk to a patient because the freedom ac power supply was not in use by a patient at the time of the customer-reported issue.In addition, it would not prevent a freedom driver from performing its life-sustaining functions.The freedom driver is equipped with redundant power sources, including multiple rechargeable freedom onboard batteries, a backup power supply, and a car charger.The ac power supply cable was disassembled, the connector key slot was aligned with the connector cover key tab and the correct mating configuration was obtained.After the ac power supply cable was reassembled, the ac power supply passed all required functional testing.Freedom 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; ce 2652; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 4548255
• MDR Text Key: 16986983
• Report Number: 3003761017-2015-00071
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor,distributor,foreign
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 02/12/2015

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: 04/27/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2015
• 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