MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC. SYNCARDIA COMPANION HOSPITAL CART

Catalog Number P/N 397003-001

Device Problem Failure to Calibrate (2440)

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

Event Date 07/17/2023

Event Type  malfunction  

Event Description

The customer, a syncardia certified hospital, reported that the hospital cart display screen calibration is off - very difficult to push buttons effectively.Clinical support specialist tried twice to recalibrate screen as did one of the vad coordinators on site.It would not recognize our finger during recalibration.

Manufacturer Narrative

The hospital cart will be returned to syncardia for evaluation.The results will be provided in a follow-up mdr.

Manufacturer Narrative

Device history record (dhr) review confirmed that hospital cart s/n (b)(6) was serviced and passed all functional testing prior to being released to finished goods.Visual inspection of external and internal components found no abnormalities.Hospital cart passed all functional testing for acceptance at incoming inspection.Touchscreen calibration was performed per procedure.Touchscreen worked as designed and was successfully calibrated.Failure investigation for this complaint could not confirm the reported issue.Customer complaint could not be replicated; root cause of the calibration issue could not be determined.Failure investigation identified no test failures or damage that could have contributed to the complaint.No evidence of a device malfunction was found.Hospital cart 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

The customer, a (b)(6) hospital, reported that the hospital cart display screen calibration is off - very difficult to push buttons effectively.Clinical support specialist tried twice to recalibrate screen as did one of the vad coordinators on site.It would not recognize our finger during recalibration.

• Brand Name: SYNCARDIA COMPANION HOSPITAL CART
• Type of Device: HOSPITAL CART
• 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: 17408420
• MDR Text Key: 320159015
• Report Number: 3003761017-2023-00109
• 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: 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: P/N 397003-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2014
• 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: 59 YR
• Patient Sex: Male