MAUDE Adverse Event Report: CONMED UTICA HEARTBEAT;100;TAB;ADGEL; ELECTRODE, ELECTROCARDIOGRAPH

Model Number	1925-100
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The distributor reported on behalf of their customer that the 1925-100, heartbeat;100;tab;adgel, was reported as used during an urgent ecg on (b)(6) 2022 when it was reported, ¿new ecg electrodes that came with the new ge macvu 360 ecg machine, do not adhere to patients well.Multiple complaints from nursing and lab.Most recent incident was a patient needing an urgent ecg and we could not obtain a tracing.Ran over to lab to find some older product (kenlor/covidien pads) and the ecg was completed.¿ there was no report of injury, medical intervention, or hospitalization for the patient or the user.The procedure was reported as being completed with an alternate pad.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.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The distributor reported on behalf of their customer that the 1925-100, heartbeat;100;tab;adgel, was reported as used during an urgent ecg on (b)(6) 2022 when it was reported, ¿new ecg electrodes that came with the new ge macvu 360 ecg machine, do not adhere to patients well.Multiple complaints from nursing and lab.Most recent incident was a patient needing an urgent ecg and we could not obtain a tracing.Ran over to lab to find some older product (kenlor/covidien pads) and the ecg was completed.¿ there was no report of injury, medical intervention, or hospitalization for the patient or the user.The procedure was reported as being completed with an alternate pad.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Performed a visual inspection, no abnormalities or defects.Per an additional evaluation performed by r&d, the product was tested by applying to skin for 30 minutes just as the recommended time frame, and there were no issues.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.This is the only complaint for this lot number and failure mode within the past two years.(b)(4).Per the instructions for use, the user is advised the electrode sites should be clean, dry, and free from skin oil prior to electrode application.Fluids, including skin cleansing solutions, lotions or soapy water may cause skin irritation and loss of adhesion.Keep electrode site dry.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: HEARTBEAT;100;TAB;ADGEL
• Common Device Name: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): CONMED UTICA; 525 french rd; utica NY 13502
• Manufacturer (Section G): CONMED UTICA; 525 french rd; utica NY 13502
• Manufacturer Contact: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 15094835
• Report Number: 1320894-2022-00164
• Device Sequence Number: 14783058
• Product Code: DRX
• UDI-Device Identifier: 10653405033714
• UDI-Public: (01)10653405033714(17)231025(10)202110251
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K910494
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2022

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 Expiration Date: 10/25/2023
• Device Model Number: 1925-100
• Device Catalogue Number: 1925-100
• Device Lot Number: 202110251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/04/2022
• Supplement Date Received by Manufacturer: 10/04/2022
• Initial Report FDA Received Date: 07/25/2022
• Supplement Report FDA Received Date: 10/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GE MACVU 360 ECG MACHINE; GE MACVU 360 ECG MACHINE; KENLOR/COVIDIEN PADS; KENLOR/COVIDIEN PADS
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic