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

Catalog Number 295050-001

Device Problems Loose or Intermittent Connection (1371); Connection Problem (2900); Power Problem (3010)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/21/2015

Event Type  malfunction  

Event Description

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 the connection from the freedom a/c power supply to the freedom driver was loose, but remained connected.There was no reported adverse patient impact.This alleged failure mode poses a low risk to the patient because although the connection from the freedom a/c power supply to the freedom driver was loose, the driver continued to perform its life-sustaining functions.In addition, the freedom 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).

Event Description

The freedom ac power supply is a component that enables the freedom driver to be plugged into an external power source.The customer reported that the connection from the freedom ac power supply to the freedom driver was loose, but remained connected.There was no reported adverse patient impact.Visual inspection of the freedom ac power supply revealed a broken strain relief for the power adaptor connector end and a missing rubber foot.These are not related to the customer reported issue and are likely the result of rough handling of the power supply.Freedom ac power supply s/n (b)(4) did not meet the visual inspection requirements, but did meet all electrical and functional test acceptance criteria.The customer reported loose connection was not duplicated.This failure mode poses a low risk to a patient because the loose connection did not prevent the freedom driver from performing its life-sustaining functions.The freedom driver is also equipped with redundant power sources, including multiple rechargeable freedom onboard batteries and a car charger.Freedom ac power supply will be taken out of service because of the broken strain relief and missing rubber foot.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: 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: 4488073
• MDR Text Key: 5499557
• Report Number: 3003761017-2015-00046
• 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
• Report Date: 01/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2015
• 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: 02/12/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2013
• 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: 64 YR