MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA FREEDOM HOME AC POWER SUPPLY

Catalog Number 295600-003

Device Problems Electrical /Electronic Property Problem (1198); Device Inoperable (1663); Device Operational Issue (2914)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 11/24/2017

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to a patient because this issue was observed when the freedom home ac power supply was not in use by a patient.The freedom home 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).

Event Description

The freedom home ac power supply is a component that enables the freedom driver to be plugged into an external power source.The customer, a syncardia certified hospital, reported that the freedom home ac power supply does not work.

Manufacturer Narrative

The results of the supplier evaluation concluded that the positive and negative wires on the output cord were reversed on the printed circuit board (pcb).The root cause was determined to be that the wires were installed incorrectly.(b)(4) follow-up report 2.

Manufacturer Narrative

The freedom home ac power supply was returned to syncardia for evaluation.Investigation testing confirmed the customer-reported issue and verified that the home ac power supply had an internal electrical problem that disabled the unit from outputting a voltage.However, because the freedom home ac power supply is an off-the-shelf component, no further mechanical disassembly or electrical diagnostic tests were performed by syncardia.The unit will be returned to the supplier for root cause analysis.The results of the supplier evaluation will be provided in a follow-up mdr.(b)(4) follow-up report 1.

Event Description

The freedom home ac power supply is a component that enables the freedom driver to be plugged into an external power source.The freedom home ac power supply was not supporting a patient.The customer, a syncardia certified hospital, reported that the freedom home ac power supply did not work.

• Brand Name: SYNCARDIA FREEDOM HOME AC POWER SUPPLY
• Type of Device: AC POWER SUPPLY
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• MDR Report Key: 7084349
• MDR Text Key: 94991205
• Report Number: 3003761017-2017-00245
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 12/05/2018

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: Health Professional
• Device Catalogue Number: 295600-003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2017
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/24/2017
• Initial Date FDA Received: 12/05/2017
• Supplement Dates Manufacturer Received: 04/19/2018; 04/19/2018
• Supplement Dates FDA Received: 05/04/2018; 12/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1