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

Catalog Number 295400-002

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/18/2016

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).

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 cable connector is cracked.The customer also reported that there was no clinical impact on the patient, and that the patient was given a replacement ac power supply.

Manufacturer Narrative

The (b)(6) ac power supply eu was returned to syncardia for evaluation.Visual inspection of the freedom hospital ac power supply's exterior components revealed a cracked hypertronics connector.The customer-reported issue was verified.The root cause of the damage is unknown; however, damage to connectors is usually a result of rough handling, including being dropped or stepped on.Despite the visual damage to the connector, the (b)(6) ac power supply passed all electrical functional testing.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) follow-up report 1.

Event Description

The (b)(6) ac power supply is a component that enables the freedom driver to be plugged into an external power source.The customer reported that the cable connector is cracked.The customer also reported that there was no clinical impact on the patient, and that the patient was given a replacement ac power supply.

• 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: michael garippa ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 6059349
• MDR Text Key: 58820565
• Report Number: 3003761017-2016-00358
• 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: 10/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2016
• 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: 10/28/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2016
• 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: 36 YR