MAUDE Adverse Event Report: CONMED UTICA CONMED; PUMP, INFUSION

Catalog Number	270179
Medical Device Problem Code	Unintended Electrical Shock (4018)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	07/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A sales representative reported on behalf of a customer that the 270179, infuser compressor 110v 60 hz device was used in an unnamed procedure on approximately on (b)(6) 2025, and ¿cap to fuse broke off causing it to lightly shock people (everyone's okay)¿.Through follow-up assessment, the customer "confirmed it was only one person who got shocked.They pulled the equipment out of the or right after the case and it wasn't used again.".There was no report of injury, medical/surgical intervention, or extended hospitalization for the patient or user.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
A sales representative reported on behalf of a customer that the 270179, infuser compressor 110v 60 hz device was used in an unnamed procedure on approximately (b)(6) 2025, and ¿cap to fuse broke off causing it to lightly shock people (everyone's okay)¿.Through follow-up assessment, the customer "confirmed it was only one person who got shocked.They pulled the equipment out of the or right after the case and it wasn¿t used again.".There was no report of injury, medical/surgical intervention, or extended hospitalization for the patient or user.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The mounting post was loose.The repair was completed and the final test met all specifications.The preventative maintenance was not overdue.Root cause cannot be determined, however, based upon evaluation of the device, review of drawing, and the ifu; a possible cause of this event could be loose components.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.The service history was reviewed, and no prior data was found.A two-year review of complaint history revealed there has been a total of two reports, regarding two devices, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be (b)(4).We will continue to monitor per regulatory requirements to help ensure patient safety.

• Brand Name: CONMED
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): CONMED UTICA; 525 french rd; utica NY 13502
• Manufacturer (Section G): CONMED UTICA; 525 french rd; utica NY 13502
• Manufacturer Contact: beth madeline ; 11311 concept blvd; largo, FL 33773 ; 7274708358
• MDR Report Key: 22609997
• Report Number: 1320894-2025-00181
• Device Sequence Number: 9564774
• Product Code: FRN
• UDI-Device Identifier: 30653405048026
• UDI-Public: (01)30653405048026(11)250327
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K990447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 270179
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2025
• Supplement Date Received by Manufacturer: 08/26/2025
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic