MAUDE Adverse Event Report: GYRUS ACMI, INC MULTIDEBRIDER POWER CONSOLE

Model Number MDCONS100

Device Problems Failure to Power Up (1476); Output Problem (3005); Intermittent Energy Output (4025)

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

Event Type  malfunction  

Manufacturer Narrative

The returned device was evaluated.Inspection found that the reported issue was not confirmed.During testing, all output powers were observed to be within specifications, leakage test passed and no issues were found.In addition, burn in testing was performed and device was turned on and off for few times and the reported issue was not able to be duplicated.The unit passed all functional testing with no errors observed.Unrelated to the reported issue, minor scratches and dents were found on the housing unit and new version card edge board was noted on the device.Based on evaluation findings the reported issue was not able to be duplicated as no problem found on the device during testing.This report will be supplemented accordingly following investigations.

Event Description

A report of main console not functioning as intended, system is not booting up with bipolar mode working intermittently during preparation for use was reported.No patient involvement, no user injury reported due to the event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation.The following sections were updated: g3, g6, h2, h4, h6, and h10.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the legal manufacturer's investigation, the root cause has determined to be user error as the customer phenomenon could not be replicated.

• Brand Name: MULTIDEBRIDER POWER CONSOLE
• Type of Device: MULTIDEBRIDER POWER CONSOLE
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 11713079
• MDR Text Key: 256689533
• Report Number: 1037007-2021-00029
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00821925027770
• UDI-Public: 00821925027770
• Combination Product (y/n): N
• PMA/PMN Number: K123429
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 05/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MDCONS100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1