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

Catalog Number	397003-001
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The hospital cart will be returned to syncardia for evaluation.The results will be provided in a follow-up mdr.
Event or Problem Description
The customer, a syncardia authorized distributor, reported the hospital cart switched to battery power while connected to ac power.The power cable was replaced but the issue persisted with the cart.
Additional Manufacturer Narrative
Device history record (dhr) review confirmed that companion hospital cart s/n (b)(6) passed all functional testing as a new build and met all required specifications prior to being shipped for use.Visual inspection and functional testing could not be completed as the device was not returned to the manufacturer.Several attempts were made over the course of two years to acquire the equipment, however, the customer communicated that they will not return the device.The device is not currently in use as the customer does not have any implanted patients or implantable devices for future implants.Failure investigation for this complaint could not confirm the reported issue.Historical investigations for similar issues with the hospital cart not recognizing a/c power have identified voltage dropping at the docking connector as a possible cause, however, this cannot be confirmed due to the device not being returned.No device malfunction was found as there is not enough evidence to complete an investigation.No adverse patient impact was reported.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
The customer, a syncardia authorized distributor, reported the hospital cart switched to battery power while connected to ac power.The power cable was replaced but the issue persisted with the cart.

• Brand Name: SYNCARDIA 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: michael larsen ; 1992 e silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 16872953
• Report Number: 3003761017-2023-00068
• Device Sequence Number: 12127660
• Product Code: LOZ
• UDI-Device Identifier: 00858000003138
• UDI-Public: (01)00858000003138
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• 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: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2025

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?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2023
• Supplement Date Received by Manufacturer: 04/25/2023
• Initial Report FDA Received Date: 05/04/2023
• Supplement Report FDA Received Date: 05/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 14 YR
• Patient Sex: Male