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

Catalog Number 295400-001

Device Problem Material Integrity Problem (2978)

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

Event Date 10/01/2021

Event Type  malfunction  

Event Description

The freedom hospital ac power supply is a component that enables the freedom driver to be plugged into an external power source.The customer, a syncardia certified hospital, reported that the freedom hospital ac power supply had a damaged connector.The freedom hospital ac power supply was not supporting a patient.

Manufacturer Narrative

The freedom hospital ac power supply will be returned to syncardia for evaluation.The results will be provided in a follow-up mdr.(b)(4).

Manufacturer Narrative

During visual inspection, damage to the connector was confirmed.Additionally, one of the four power supply rubber feet were missing and physical damage was observed on the power brick.The investigation confirmed the customer-reported issue.The observed damage was mostly likely due to accidental rough handling.The power supply's functionality was not able to be evaluated due to the physical damage.This issue will be monitored and trended as part of the customer experience process.Syncardia has completed its investigation and is closing this file.(b)(4) follow-up report 1.

• Brand Name: SYNCARDIA FREEDOM HOSPITAL 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: kerri hensley ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 13025090
• MDR Text Key: 284354809
• Report Number: 3003761017-2021-00235
• 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: 03/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 295400-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2021
• 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: 50 YR
• Patient Sex: Female