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

Catalog Number 295400-001

Device Problems Sticking (1597); Power Problem (3010)

Patient Problem No Patient Involvement (2645)

Event Date 05/08/2017

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 during a training session the freedom hospital ac power supply did not come out of a freedom driver easily.It was noted that the connector collar was stuck in the down position.

Manufacturer Narrative

The (b)(6) hospital ac power supply was returned to syncardia for evaluation.Functional testing showed that the spring legs on the hypertronics connector would not protrude from the outer housing when the cover was released after pulling back, which is the intended design.This indicates that the connector was not performing as intended and could cause difficulty when inserting or removing from the receptacle.The (b)(6) hospital ac power supply was found to be electrically sound and operated as intended for power delivery.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) hospital ac power supply is a component that enables the freedom driver to be plugged into an external power source.The (b)(6) hospital ac power supply was not supporting a patient.The customer, a syncardia certified hospital, reported that during a training session the (b)(6) hospital ac power supply did not come out of a (b)(6) driver easily.It was noted that the connector collar was stuck in the down position.

• 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: 6559316
• MDR Text Key: 75016968
• Report Number: 3003761017-2017-00081
• 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: 05/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 295400-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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