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

Model Number 777000

Device Problems Defective Component (2292); Output Problem (3005)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The evaluation determined the device core of the transformer on the pkrf board was broken causing low output.During testing, the unit was found to have a faulty auxiliary board.In addition, multiple scratches were observed on the top case.The key pad membrane was determined to have multiple scratches and a hole puncture.The software version required upgrade.Review of data log revealed no error(s) observed.The identified parts were replaced and device was repaired.The software version was upgraded.Once completed, the device was tested and passed required testing, and specifications.The reported failure was found to be electrical component failures of the pkrf board and the auxiliary board.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 a broken transformer core and with low output.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 final investigation.The following sections were updated: g4, g7, h2, h4, h6, and h10.Based on the legal manufacturer¿s investigation, the device history record (dhr) was reviewed and there were no problems found during the manufacturing of the device that would cause or contribute to the reported issue.The device met all specifications at the time of shipment.

• 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: 11031597
• MDR Text Key: 223806470
• Report Number: 3003790304-2020-00141
• 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
• Type of Report: Initial,Followup
• Report Date: 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1