MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC SYNCARDIA COMBAION EXTERNAL LI-BATTERY PACK

Model Number	293001-001
Medical Device Problem Codes	Power Problem (3010); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The companion external battery will be returned to syncardia for evaluation.The results will be submitted in a follow-up mdr.(b)(4).
Event or Problem Description
The companion external battery was not supporting a patient.The customer, a syncardia authorized distributor, reported that companion external battery did not charge after one week in the companion 2 driver.
Additional Manufacturer Narrative
The battery's system management (smbus) data was reviewed and no faults were recorded.The battery passed all sections of the evaluation procedure.Since the customer stated that the battery would not charge while installed in a companion 2 driver, additional testing with a known functioning driver was performed.The investigation testing demonstrated that the battery was capable of both charging and discharging in a companion 2 driver.The root cause of customer-reported companion external battery not charging in a companion 2 driver could not be determined.The battery performed as intended with no evidence of a device malfunction.This issue will be tracked and trended as part of the customer complaint process.Syncardia has completed its investigation and is closing this file.(b)(4) follow-up report 1.

• Brand Name: SYNCARDIA COMBAION EXTERNAL LI-BATTERY PACK
• Common Device Name: BATTERY PACK
• 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: sagar pimpalwar ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 11832369
• Report Number: 3003761017-2021-00087
• Device Sequence Number: 17254131
• Product Code: LOZ
• UDI-Device Identifier: 00858000003077
• UDI-Public: (01)00858000003077
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2022

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 Model Number: 293001-001
• Device Catalogue Number: 293001-001
• 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: 04/30/2021
• Supplement Date Received by Manufacturer: 04/30/2021
• Initial Report FDA Received Date: 05/17/2021
• Supplement Report FDA Received Date: 08/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2017
• 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