MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC. SYNCARDIA COMPANION 2 DRIVER; EXTERNAL PNEUMATIC DRIVER

Catalog Number P/N 397002-001

Device Problems Break (1069); No Apparent Adverse Event (3189)

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

Event Date 05/04/2023

Event Type  malfunction  

Manufacturer Narrative

The companion 2 driver will be returned to syncardia for evaluation.The results will be provided in a follow-up mdr.

Event Description

The customer, a syncardia certified hospital, reported the key to the driver broke off during demonstration.The driver was not supporting a patient at the time of the event.

Manufacturer Narrative

Alarm history and patient data file review found no new alarms recorded in the c2 driver data file nor any other indication of a device malfunction.Patient data file review showed a depleted 9v battery.Visual inspection of external components identified a broken key in the keyswitch.Visual inspection of external components revealed damage to two capacitors which are unrelated to this complaint.Companion 2 driver failed incoming functional testing for the system check test related to the 9v battery test portions.Testing was not able to replicate the condition with the depleted 9v battery installed.The 9 v battery was replaced and functional testing was again performed without issue.Failure investigation for this complaint confirmed the customer reported issue via patient data file review and visual inspection.The complaint was not replicated via functional testing.This driver was received at syncardia with the key broken and the switch turned to the "on" position.This condition triggers the main alarm buzzer to turn on once the internal emergency battery becomes depleted.The constant alarm is powered by the 9v battery which will become depleted.There was no evidence of a device failure caused by the broken key other than the 9v battery becoming depleted.No additional issues were found with the key during the investigation.Since the damage to the key was reported to have been directly caused by facility personnel, it is not a device malfunction.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.)" (b)(4) follow-up report 1.

• Brand Name: SYNCARDIA COMPANION 2 DRIVER
• Type of Device: EXTERNAL PNEUMATIC DRIVER
• 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: aaron meier ; 1992 e. silverlake road; tucson, AZ 85713 ; 5205451234
• MDR Report Key: 16997708
• MDR Text Key: 315921107
• Report Number: 3003761017-2023-00073
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: P/N 397002-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2015
• 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