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

Catalog Number	397003-001
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Per hospital staff, the hospital cart screen was black when the companion 2 driver was connected.The touch screen still functioned but the screen did not light up.
Event or Problem Description
Per hospital staff, the hospital cart screen was black when the companion 2 driver was connected.The touch screen still functioned but the screen did not light up.
Additional Manufacturer Narrative
Device history record (dhr) review confirmed that (b)(6) 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 scuffs on the front skin.Visual inspection of internal components found dust debris in the hospital cart chassis and a blown diode on the inverter board of the lcd display.Damage was also found to a cable pin connector and the display neck bracket welding joint.Hospital cart failed functional testing for acceptance at incoming inspection due to lcd malfunctions, confirming the screen issue in the original complaint.Additional testing included replacing the lcd module, due to the damaged diode.Cart passed functional testing with the replacement screen.Reported "burning smell" was not replicated or observed during investigation.Failure investigation for this complaint confirmed the reported issue of the black screen.The customer complaint was replicated during functional testing; the root cause of the reported screen issue was determined to be a nonconforming lcd module.The reported "burning smell" was not confirmed or replicated, however, the burnt diode may have contributed to the reported smell.The root cause of the blown diode was unable to be determined.Failure investigation identified no other test failures or damage that could have contributed to the event.Damage found to the cable pin connector and display neck bracket was cosmetic only and does not affect the functionality of the driver.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.

• 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: 18812823
• Report Number: 3003761017-2024-00064
• Device Sequence Number: 19914583
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2024

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: 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: 02/21/2024
• Initial Report FDA Received Date: 02/29/2024
• Supplement Report FDA Received Date: 09/03/2024
• 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