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

Catalog Number 295600-001

Device Problem Fracture (1260)

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

Event Date 11/14/2022

Event Type  malfunction  

Event Description

During routine evaluation, a syncardia technician reported that the freedom home ac power supply had a broken spring leg.

Manufacturer Narrative

The freedom home ac power supply will be evaluated.The results will be provided in a follow-up mdr.

• Brand Name: SYNCARDIA 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: 15877396
• MDR Text Key: 304966748
• Report Number: 3003761017-2022-00132
• 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: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 295600-001
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/14/2022
• 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