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

Catalog Number	P/N 397003-001
Medical Device Problem Codes	No Display/Image (1183); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Monitor/screen of hospital cart is blank.C2 driver screen does not project to hospital cart screen.
Additional Manufacturer Narrative
Device history record (dhr) review confirmed that companion hospital cart s/n (b)(6) was serviced and passed all functional testing prior to being released to finished goods.Visual inspection of external components found the front swivel skin at the rotating arm damaged.Visual inspection of internal components found the display neck bracket weld point damaged.Device failed functional testing for acceptance at incoming inspection due to a blank display.Inspection found the touchscreen and leds were functional but the screen was blank.Additional testing including installing a known functional lcd module.Hospital cart screen functioned normally with the replacement part.Specifically, the issue was suspected to be the inverter board.This part was installed into the functional screen, replicating the original issue with a blank screen.The lcd assembly will be replaced to address the malfunctioning part.Failure investigation for this complaint confirmed the reported issue during functional testing.The customer complaint was replicated during testing; the root cause of the reported blank hospital cart screen was determined to be a nonconforming display assembly, specifically, the inverter board of the lcd module.Failure investigation identified no other test failures or damage that could have contributed to the reported complaint.Damage found was cosmetic only and would not affect functionality of the device.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 or Problem Description
Monitor/screen of hospital cart is blank.C2 driver screen does not project to hospital cart screen.

• Brand Name: SYNCARDIA COMPANION HOSPITAL CART
• Common Device Name: 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: maia kirk ; 1992 e silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 17901725
• Report Number: 3003761017-2023-00140
• Device Sequence Number: 18053682
• Product Code: LOZ
• UDI-Device Identifier: 00858000003138
• UDI-Public: (01)00858000003138
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P030011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: P/N 397003-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/22/2023
• Initial Report FDA Received Date: 10/09/2023
• Supplement Report FDA Received Date: 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown