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

Model Number 293001-001

Device Problems Power Problem (3010); Appropriate Term/Code Not Available (3191)

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

Event Date 04/30/2021

Event Type  malfunction  

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 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.

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
• Type of Device: 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
• MDR Text Key: 253199167
• Report Number: 3003761017-2021-00087
• Device Sequence Number: 1
• Product Code: LOZ
• UDI-Device Identifier: 00858000003077
• UDI-Public: (01)00858000003077
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 04/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2017
• 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