MAUDE Adverse Event Report: KATECHO, INC. PADPRO; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Catalog Number	2516M
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not expected to be returned for evaluation and review.However, the complaint investigation is not complete at this time.A supplemental and final report will be filed following the completion of the complaint investigation.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
The distributor reported on behalf of the customer that the 2516m, defib electrode adult, radiotranslucent pads, medtronic conn, device lot number y11012403 was being used during a non-surgical procedure on an unknown date when it was reported, ¿the issue is that the adhesive has failed on nearly all of these regardless of when we have used them.During a cardiac arrest i have several reports of my staff having to hold the pads on the patient with their own hands just to deliver a shock.¿ further assessment questioning found that they are reporting that since we switched to the conmed product the items have not been functioning properly where the adhesive does not stick on the patient and the medics were being required to hold the electrodes in place by hand even during a shock.This was not reported to conmed previously, you can proceed with this being a single incident since i have no specific dates or patient details.There was no report of injury, medical intervention, or extended hospitalization for the patient.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Event or Problem Description
The distributor reported on behalf of the customer that the 2516m, defib electrode adult, radiotranslucent pads, medtronic conn, device lot number: y11012403 was being used during a non-surgical procedure on an unknown date when it was reported, ¿the issue is that the adhesive has failed on nearly all of these regardless of when we have used them.During a cardiac arrest i have several reports of my staff having to hold the pads on the patient with their own hands just to deliver a shock¿.Further assessment questioning found that they are reporting that since we switched to the conmed product the items have not been functioning properly where the adhesive does not stick on the patient and the medics were being required to hold the electrodes in place by hand even during a shock.This was not reported to conmed previously, you can proceed with this being a single incident since i have no specific dates or patient details.There was no report of injury, medical intervention, or extended hospitalization for the patient.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Reported event ¿adhesive does not stick on the patient and the medic¿s were being required to hold the electrodes in place by hand even during a shock¿ was unconfirmed.An examination of returned unused/unopened device 2516m found that the adhesive was sticky, and sticks to the skin as it should.This device had a different lot number.Lot number: y05032402.No fault found with this device.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.A two-year lot history review shows a total of nine (9) devices for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 6 complaints, regarding 63 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).Per the instructions for use, the user is advised to not use if packaging appears to be compromised.Damaged packaging may cause the conductive polymer gel to dry out.Electrodes must be used before date indicated on package.Do not open package until immediately prior to use.Visually examine the pad before placement.Check that adhesive is intact and undamaged.Do not use any damaged pads, replace pads if necessary.We will continue to monitor per regulatory requirements to help ensure patient safety.

• Brand Name: PADPRO
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): KATECHO, INC.; 4020 gannett avenue; des moines IA 50321
• Manufacturer (Section G): KATECHO, INC.; 4020 gannett avenue; des moines IA 50321
• Manufacturer Contact: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 21167227
• Report Number: 1320894-2025-00018
• Device Sequence Number: 4275836
• Product Code: MKJ
• UDI-Device Identifier: 10653405042624
• UDI-Public: (01)10653405042624(17)271101(10)Y11012403
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P200004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2025

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: 2516M
• Device Lot Number: Y11012403
• 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: 01/09/2025
• Supplement Date Received by Manufacturer: 01/29/2025
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic