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

Catalog Number 295400-001

Device Problems Physical Property Issue (3008); Power Problem (3010)

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

Event Date 12/08/2016

Event Type  malfunction  

Manufacturer Narrative

This alleged failure mode poses a low risk to a patient because the issue was observed when the freedom hospital ac power supply was not supporting a patient.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 freedom hospital ac power supply was not supporting a patient.The customer, a syncardia certified hospital, reported that the freedom hospital ac power supply had a depressed pin where the power supply connects into the freedom driver ac power adaptor.

Manufacturer Narrative

The freedom hospital ac power supply was returned to syncardia for evaluation.External visual inspection of the freedom hospital ac power supply revealed a depressed pin in the hypertronics connector.The root cause of the pin damage could not be conclusively determined based upon the information provided in the customer report; however, damage of this nature typically results from applying excessive force to the connector during the mating process when an obstruction is present in the connector barrel.Functional testing determined that freedom hospital ac power supply conformed to all functional test acceptance criteria; however, the unit did not meet the mechanical inspection criteria due to the depressed pin in the hypertronics connector.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 freedom hospital ac power supply is a component that enables the freedom driver to be plugged into an external power source.The freedom hospital ac power supply was not supporting a patient.The customer, a syncardia certified hospital, reported that the freedom hospital ac power supply had a depressed pin where the power supply connects into the freedom driver ac power adaptor.

• Brand Name: SYNCARDIA FREEDOM HOSPITAL AC POWER SUPPLY
• 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: 6186719
• MDR Text Key: 63189232
• Report Number: 3003761017-2016-00398
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/08/2016

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: Biomedical Engineer
• Device Catalogue Number: 295400-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2016
• Initial Date FDA Received: 12/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2015
• 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