MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA COMPANION 2 DRIVER; EXTERNAL PNEUMATIC DRIVER

Catalog Number 397002-001

Device Problem Noise, Audible (3273)

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

Event Date 08/15/2023

Event Type  malfunction  

Event Description

C2 driver, sn: (b)(6), was delivered by facility request.When taken out of the packaging and tested, the c2 driver is making a high pitched squealing.The driver was working as intended, but with this additional sound.We feel that this sound is abnormal and should be sent back for evaluation by syncardia.We would like to send back c2 driver, (b)(6), for evaluation of this high pitched noise.

Manufacturer Narrative

Device history record (dhr) review confirmed that companion 2 driver s/n (b)(6) was serviced and passed all functional testing prior to being released to finished goods.Alarm history and patient data file review found no new alarms.Visual inspection of external components found no abnormalities.Visual inspection of internal components found minor damage on the power management board.Companion 2 driver passed all areas of functional testing at incoming inspection.Observational testing found that the right vacuum blower was louder than the left side vacuum.Additional testing confirmed that the right vacuum did create a high pitched noise that was eliminated when replaced.This is not a device malfunction but did replicate the customer complaint.Failure investigation for this complaint confirmed the reported issue.The complaint was replicated and observed during testing; root cause of loud vacuum blower cannot be determined and did not affect functionality of device, however, the part will be dispositioned for noisiness.Failure investigation identified no test failures or damage that could have contributed to the complaint.Damage observed on the power management board is a known issue that is currently being investigated but did not contribute to reported issue.Driver functioned as designed.Device was not in patient use at time of complaint.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

C2 driver, sn (b)(6), was delivered by facility request.When taken out of the packaging and tested, the c2 driver is making a high pitched squealing.The driver was working as intended, but with this additional sound.We feel that this sound is abnormal and should be sent back for evaluation by syncardia.We would like to send back c2 driver, (b)(6), for evaluation of this high pitched noise.

• Brand Name: SYNCARDIA COMPANION 2 DRIVER
• Type of Device: EXTERNAL PNEUMATIC DRIVER
• 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: 17892029
• MDR Text Key: 326018959
• Report Number: 3003761017-2023-00123
• 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: Other Health Care Professional
• 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: 397002-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/06/2023
• Supplement Dates Manufacturer Received: 08/18/2023
• Supplement Dates FDA Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1