MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC FREEDOM HOME AC POWER SUPPLY; EXTERNAL POWER SUPPLY

Catalog Number P/N 295600-001

Device Problems Break (1069); Power Problem (3010); No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/04/2023

Event Type  malfunction  

Manufacturer Narrative

Freedom home ac power supply will be returned to syncardia for evaluation.Evaluation details will be provided in a follow up mdr.

Event Description

Patient's mother contacted vcu vad coordinator to let them know that ac power supply "not working".It appears plug portion has some physical damage.

Manufacturer Narrative

Device history record (dhr) review confirmed that home ac power supply s/n (b)(6) was serviced and passed all functional testing prior to being released to finished goods.Visual inspection of component found damage to multiple areas of the power supply housing, three of four rubber feet missing, both cable strain reliefs damaged, and the power supply connector outer housing cracked in multiple places.Home ac power supply passed electrical functional testing but failed overall testing for acceptance due to severe damage.Failure investigation for this complaint confirmed the reported issue during visual inspection.Customer complaint was replicated during testing; root cause of the malfunctioning ac power supply was determined to be extensive damage sustained during use.Root cause of the damage was unable to be determined and was not reported from the customer.Failure investigation identified no other test failures that could have contributed to the complaint.Patient was switched to a backup ac power supply with no reported adverse impact.This issue will be monitored and trended as part of the customer complaint process.Syncardia has completed its evaluation and is closing this file.If new or additional information is received in the future, syncardia will file a follow-up mdr.

Event Description

Patient's mother contacted vcu vad coordinator to let them know that ac power supply "not working".It appears plug portion has some physical damage.

• Brand Name: FREEDOM HOME AC POWER SUPPLY
• Type of Device: EXTERNAL POWER SUPPLY
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 e silverlake road; tucson AZ 85713
• Manufacturer (Section G): SYNCARDIA SYSTEMS, LLC; 1992 e silverlake road; tucson AZ 85713
• Manufacturer Contact: aaron meier ; 1992 e silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 17901571
• MDR Text Key: 325264901
• Report Number: 3003761017-2023-00131
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: P/N 295600-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/04/2023
• 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: 32 YR
• Patient Sex: Male