MAUDE Adverse Event Report: GYRUS ACMI, INC G400 GENERATOR, GYRUS

Model Number 777000

Device Problem Output Problem (3005)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device was received and evaluated.Evaluation determined that the device failed testing, exhibited error code 200 ref 53 due to faulty plasma blend board.In addition, voltage and current check lamp, unstable due to faulty pkrf board.Review of data log revealed error 200 ref 43 (post failure) showed one time in the log.The identified parts were replaced, device was repaired and the fault log has been cleared.Once completed, the device passed all required electrical safety , functional testing and specifications.Based on evaluation findings the reported failure was found to be due to component failure attributed to electrical component failure.Once replaced, device was tested , passed required testings and no other issues reported.This mdr is being submitted retrospectively as part of a remediation effort related to the recent system and process changes.A capa has been opened to manage the actions related to remediation of this issue and any required reporting.

Event Description

It was reported that during an asset return inspection the device was observed with error code 200 ref 53, failed due to faulty plasma board and pkrf board.There was no patient involvement on this reported event.No user injury reported.

Manufacturer Narrative

This supplemental report is being submitted to provide service history record (shr), unique device identifier (udi) number, trend analysis and investigation conclusion.The device had been previously serviced by olympus therefore a service history review will replace (dhr) device history record review.Review of the previous service shows no abnormalities.Olympus will continue to monitor the field performance of this device.

• Brand Name: G400 GENERATOR, GYRUS
• Type of Device: G400 GENERATOR, GYRUS
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 11014990
• MDR Text Key: 221762233
• Report Number: 3003790304-2020-00140
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K050550
• 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: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 777000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1