MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA FREEDOM AC POWER ADAPTOR; AC POWER ADAPTER

Catalog Number 295070-001

Device Problems Device Operates Differently Than Expected (2913); Power Problem (3010)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 12/06/2014

Event Type  malfunction  

Event Description

The customer reported that the patient did not see a green light on this freedom power adaptor while being supported by the freedom driver.The patient switched the freedom power adaptor without adverse impact.This alleged failure mode poses a low risk to the patient because it did not prevent the freedom power adaptor and the freedom driver from performing its life sustaining functions.In addition, the freedom driver has a redundant power source onboard batteries.The freedom power adaptor will be returned to syncardia for evaluation.The results of the investigation will be provided in a supplemental mdr.

Manufacturer Narrative

(b)(4).

Event Description

The customer reported that the patient did not see a green light on the freedom power adaptor while being supported by the freedom driver.The customer also reported that the patient observed that the freedom driver was operating on battery power while the freedom ac power supply was connected to wall power.The patient was provided with a replacement freedom power adaptor and freedom ac power supply.There was no reported adverse patient impact.The freedom power adaptor and freedom ac power supply were returned to syncardia for evaluation.The freedom ac power supply was investigated under mfr #03003761017-2014-00298.Investigation of the freedom ac power supply revealed damage to the adaptor connector housing and broken strain relief, confirming the customer reported issue.The root cause of the damage to the adaptor connector housing and broken strain relief is unknown, but the damage observed is consistent with the result of rough handling.The freedom ac power supply was taken out of service.Visual inspection of the freedom power adaptor revealed no anomalies.In addition, the freedom power adaptor light was illuminated during testing and passed all testing requirements with no anomalies.The freedom power adaptor was serviced and passed all final performance testing.This alleged failure mode poses a low risk to the patient because it did not prevent the freedom driver from performing its life-sustaining functions.In addition, the freedom driver has a redundant power source of onboard batteries.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.

• Brand Name: SYNCARDIA FREEDOM AC POWER ADAPTOR
• Type of Device: AC POWER ADAPTER
• Manufacturer (Section D): SYNCARDIA SYSTEMS, INC.; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer (Section G): SYNCARDIA SYSTEMS, INC.; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: carole marcot ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 4360301
• MDR Text Key: 21553637
• Report Number: 3003761017-2014-00299
• 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 Facility,health professional,use
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 12/06/2014

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: Health Professional
• Device Catalogue Number: 295070-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2014
• Initial Date FDA Received: 12/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2014
• 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: 42 YR