MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, INC. SYNCARDIA FREEDOM POWER ADAPTOR; CIRCULATORY ASSIST DEVICE

Catalog Number 295070-001

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/02/2015

Event Type  malfunction  

Event Description

The customer reported that the pt was detaching the freedom power adaptor from the freedom a/c power supply when the green and white base became loose from its housing.The pt switched the freedom power adaptor with his backup power adaptor.There was no adverse pt impact.This alleged failure mode poses a low risk to the pt because it did not prevent the freedom driver form performing its life-sustaining functions.In addition, the freedom driver has a redundant power source of 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.

• Brand Name: SYNCARDIA FREEDOM POWER ADAPTOR
• Type of Device: CIRCULATORY ASSIST DEVICE
• Manufacturer (Section D): SYNCARDIA SYSTEMS, INC.; tucson AZ
• Manufacturer Contact: carole marcot, esg, vice pres ; 1992 e. silverlake rd.; ce 2556; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 4437269
• MDR Text Key: 20776364
• Report Number: 3003761017-2015-00334
• 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
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 01/02/2015

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: 295070-001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/02/2015
• Initial Date FDA Received: 01/15/2015
• Was Device Evaluated by Manufacturer?: No
• 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: 44 YR