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

Catalog Number 295050-001

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/25/2019

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to the patient because although the issue was observed when the freedom driver was supporting a patient, it did not prevent the device from performing its life-sustaining function.The freedom driver has a redundant power source of 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 power supply unit which has an integrated, molded wall input power cord.The home ac power supply connects the power adaptor to a wall power outlet.The customer, a syncardia certified hospital, reported that the freedom driver home ac power supply was "loose" while supporting a patient.There was no reported adverse patient impact.

Manufacturer Narrative

Visual inspection of the power supply revealed a cracked connector outer housing and four (4) missing rubber feet.The power supply passed all functional testing criteria.During investigational testing, the customer-reported loose connection could not be replicated.However, since the crack on the connector outer housing expands temporarily while external pressure is applied to it, it may be possible that the connector may come loose from the power adaptor given the right conditions.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.Ce-4869 follow-up report 1.

Event Description

Product is a freedom ac power supply, not a freedom home ac power supply.

Manufacturer Narrative

(b)(4) follow-up report 2.

• Brand Name: SYNCARDIA FREEDOM AC POWER SUPPLY
• Type of Device: EXTERNAL POWER SUPPLY
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• MDR Report Key: 8791612
• MDR Text Key: 151125586
• Report Number: 3003761017-2019-00217
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 10/21/2019

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: Lay User/Patient
• Device Catalogue Number: 295050-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2019
• Initial Date Manufacturer Received: 06/25/2019
• Initial Date FDA Received: 07/15/2019
• Supplement Dates Manufacturer Received: 06/25/2019; 06/25/2019
• Supplement Dates FDA Received: 10/21/2019; 10/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR