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

Model Number 777000

Device Problem Output below Specifications (3004)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The unit was inspected and tested.During the start up testing, the unit showed error message¿ remove instrument¿ due to faulty pkrf and auxiliary boards.Inspection of the unit found the id and pkrf boards were not properly mounted, the 3 stands on pkrf board were observed to be broken.The output testing was found low due to to faulty psu (power supply unit).The unit is running an old version software v2.04 and needs to be upgraded to v2.07.Review of the fault log shows 400 ref 25, seven times indicated that the biomed time credit expired.The biomed test cable has been used beyond its time limit allocation.Error 100 ref 12, showed one time indicated a non volatile memory corrupt or not initialized.Investigation is ongoing therefore the root cause cannot be determined at this time.If additional information becomes available this report will be supplemented accordingly.

Event Description

It was reported that during receipt inspection the unit was found with low output, reading was out of specifications.There was no patient involvement on this reported event.No user injury reported.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.All records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.Olympus will continue to monitor complaints for 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: 11154820
• MDR Text Key: 242060549
• Report Number: 3003790304-2021-00006
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00821925009004
• UDI-Public: 00821925009004
• 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: 02/05/2021

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
• Device Operator: Health Professional
• Device Model Number: 777000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/14/2020
• Initial Date FDA Received: 01/12/2021
• Supplement Dates Manufacturer Received: 01/20/2021
• Supplement Dates FDA Received: 02/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1