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

Catalog Number 295600-001

Device Problems Break (1069); Electrical /Electronic Property Problem (1198); Device Inoperable (1663); Noise, Audible (3273)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 03/13/2018

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to the patient because the reported issue would not prevent the freedom driver from performing its life-sustaining functions.The freedom driver has a redundant power source of multiple onboard batteries.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 patient turned in a broken freedom home ac power supply on his last clinic visit.The customer also reported that the cord reportedly did not work, and made a rattling noise when shaken as if something was broken inside.The customer also reported that there was no adverse patient impact.

Manufacturer Narrative

Visual inspection identified a crack in the white connector, cracks and scuffs on the power supply brick housing, and damage to the cable.The cause of the customer-reported issue of the ac power supply not providing power was determined to be a malfunction of the internal printed circuit assembly (pca), where the l3 component had detached from the board.The root cause of this detachment cannot be confirmed, but it is likely the result of a drop or other rough handling, given the observations made during the visual inspection.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation and is closing this file.(b)(4) follow-up report 1.

• 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: 7454255
• MDR Text Key: 106410785
• Report Number: 3003761017-2018-00142
• 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: health professional,user faci
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 09/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 295600-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 22 YR