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

Model Number 777000

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Patient Involvement (2645)

Event Date 04/28/2020

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer at the user facility further reported an alarm and alarm message was given on the display.However, the alarm or message displayed could not be confirmed.The generator was opened up and there was some debris/dust inside.The biomedical engineer cleaned as many connectors that were within reach with an oxidation cleaner that preserves and keeps the oxidation from happening.The connectors were also exercised.The cord was also inspected and there were no issues with the cord.The connection between the cord and equipment was secure.The concomitant devices used with the generator are unknown.The generator is currently in service at the facility and is working fine.There have not been any further complaints with the generator.A review of the service history indicated the scope was purchased on march 5, 2012 with no previous service/repair records.To date, there was no record that indicates the referenced generator was returned to the service center for evaluation; therefore, the exact cause of the reported event could not be determined.

Event Description

The technical assistance group was informed that the display of the g400 generator was distorted when powered up.Tapping on the side of housing of the generator resulted in different character displays.There was no patient involvement reported.

Manufacturer Narrative

To date, the referenced device was not returned for an evaluation.The cause of the reported event could not be determined.A device history record (dhr) review was conducted and no abnormalities were noted.

• Brand Name: G400 GENERATOR, GYRUS
• Type of Device: G400 GENERATOR
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 10080836
• MDR Text Key: 204527603
• Report Number: 3003790304-2020-00012
• 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: 06/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 777000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1