MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA FREEDOM POWER ADAPTOR; AC POWER ADAPTOR

Catalog Number 295070-001

Device Problems Device Emits Odor (1425); Overheating of Device (1437); Device Operational Issue (2914)

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

Event Date 09/19/2016

Event Type  malfunction  

Manufacturer Narrative

The freedom power adaptor was returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.(b)(4).

Event Description

The reported issue involves the following syncardia temporary total artificial heart (tah-t) system components and are reported under two separate medical device reports: freedom driver s/n (b)(4) (mfr report # 3003761017-2016-00324 and freedom power adaptor s/n (b)(4) (mfr report # 3003761017-2016-00340).The customer reported that the wife removed the power adaptor from the freedom driver because it had a 'hot' smell.

Manufacturer Narrative

The freedom power adaptor was returned to syncardia for evaluation.The freedom power adaptor passed all performance testing, and there was no evidence of a device malfunction.The customer-reported smell most likely came from the associated freedom driver (mfr report # 3003761017-2016-00324).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.Ce (b)(4) follow-up report 1 (2 of 2).

Event Description

The reported issue involves the following syncardia temporary total artificial heart (tah-t) system components and are reported under two separate medical device reports: freedom driver s/n (b)(4) (mfr report # 3003761017-2016-00324) and freedom power adaptor s/n (b)(4) (mfr report # 3003761017-2016-00340).The customer reported that the wife removed the power adaptor from the freedom driver because it had a 'hot' smell.

• Brand Name: SYNCARDIA FREEDOM POWER ADAPTOR
• Type of Device: AC POWER ADAPTOR
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e. silverlake road; tucson AZ 85713
• Manufacturer Contact: carole marcot ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 6011783
• MDR Text Key: 57323293
• Report Number: 3003761017-2016-00340
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 09/19/2016

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: Lay User/Patient
• Device Catalogue Number: 295070-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/19/2016
• Initial Date FDA Received: 10/07/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/17/2016
• 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
• Patient Age: 56 YR