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

Catalog Number 295400-002

Device Problems Break (1069); Crack (1135)

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

Event Date 09/12/2016

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to a 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 onboard batteries.The freedom hospital 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) initial.

Event Description

The freedom hospital ac power supply is a component that enables the freedom driver to be plugged into an external power source.The customer reported that the green connector is cracked.

Manufacturer Narrative

The freedom hospital ac power supply was returned to syncardia for evaluation.Visual inspection of the freedom hospital ac power supply's exterior components revealed a broken ac power cord strain relief and damage to the connector that connects to the freedom power adaptor.The reported issue that the freedom hospital ac power supply connector was damaged was verified.The root cause of the observed and reported damage is unknown; however, damage to connectors is usually because of rough handling, such as being dropped or stepped on.Despite the damage to the connector, the freedom hospital ac power supply passed all electrical functional testing, which included the ability to provide power to a freedom driver for at least one (1) minute.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.(b)(4).

Event Description

The freedom hospital ac power supply is a component that enables the freedom driver to be plugged into an external power source.The customer reported that the green connector is cracked.

• Brand Name: SYNCARDIA FREEDOM HOSPITAL AC POWER SUPPLY EU
• Type of Device: HOSPITAL AC POWER SUPPLY
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: carole marcot ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 6011759
• MDR Text Key: 57323291
• Report Number: 3003761017-2016-00320
• 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: distributor,foreign,health pr
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 09/12/2016

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: 295400-002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/12/2016
• Initial Date FDA Received: 10/07/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2016
• 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: 56 YR