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

Catalog Number 295600-001

Device Problems Power Problem (3010); Insufficient Information (3190)

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

Event Date 09/04/2023

Event Type  malfunction  

Event Description

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

Manufacturer Narrative

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

Manufacturer Narrative

Device history record (dhr) review confirmed that freedom home ac power supply s/n 10089 was serviced and passed all functional testing prior to being released to finished goods.Visual inspection found the power supply housings have damage.All the rubber feet are missing and both cable strain reliefs are damaged.The power supply connector outer housing also has multiple cracks.Device failed incoming inspection for visible damage but passed all electrical functional testing.No additional testing was performed.The customer complaint was not replicated.Failure investigation for this complaint could confirm that the freedom ac power supply was damaged in multiple areas.The specific complaint that the power supply was malfunctioning could not be replicated; root cause of the damage could not be determined.Failure investigation identified no test failures or damage that could have contributed to the complaint.Damage found to the power supply was cosmetic.Patient was switched to a backup driver without any 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 saying that ac power supply is "not working".It appears that 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: 17896802
• MDR Text Key: 325821276
• Report Number: 3003761017-2023-00130
• 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: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/12/2024

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 Catalogue Number: 295600-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/04/2023
• Initial Date FDA Received: 10/09/2023
• Supplement Dates Manufacturer Received: 09/04/2023
• Supplement Dates FDA Received: 01/12/2024
• 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