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

Catalog Number	2001Z-C
Medical Device Problem Code	Failure to Deliver Shock/Stimulation (1133)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2025
Type of Reportable Event	Malfunction
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
The customer reported that the device, 2001z-c, adult/child = 10 kg radiotransparent electrode, zoll, was being used during a transcutaneous pacing procedure on (b)(6) 2025 when it was reported, ¿zoll defibrillator failed to transcutaneously pace in 3 instances, (location).Only connection discovered so far is same lot number for defib pads¿.There was no report of injury, medical intervention, or hospitalization of the patient.When asked the reporter gave further information stating, "i would say it was a normal case that turned into an emergency.We have them on ¿just in case¿ and then, when we need them, they are there.So, in our case, we did a normal outpatient and when we needed them as a back up, that is when it failed." this report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Event or Problem Description
The customer reported that the device, 2001z-c, adult/child = 10 kg radiotransparent electrode, zoll, was being used during a transcutaneous pacing procedure on (b)(6) 2025 when it was reported, ¿zoll defibrillator failed to transcutaneously pace in 3 instances, (location).Only connection discovered so far is same lot number for defib pads¿.There was no report of injury, medical intervention, or hospitalization of the patient.When asked the reporter gave further information stating, "i would say it was a normal case that turned into an emergency.We have them on ¿just in case¿ and then, when we need them, they are there.So, in our case, we did a normal outpatient and when we needed them as a back up, that is when it failed." this report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Examination of the returned unopened/unused device 2001z-c found that there was some electric continuity issues.Received 369 of the 2001z-c adult/child 10 kg radiotransparent electrode, zoll in unopened original packaging.Sampled 29 devices and functionally inspected to find some defects.Testing the devices with the fluke 114 multimeter found 4 out of the 29 did not have electric continuity through the device.The other 25 did have electric continuity.A root cause cannot be determined; however, based upon evaluation the risk document a possible cause of this event could be that the substrate material is not conductive enough.A device history record (dhr) review was requested from the manufacturer, and no indication of abnormalities was communicated.A two-year lot history review shows a total of 3 devices for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 7 complaints, regarding 9 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 that misuse (including reuse) of multifunction electrodes, use of compromised or altered product, and/or failure to follow product instructions may result in patient burns, inadequate delivery of therapy, and/or loss of ecg trace quality.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: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 22902176
• Report Number: 1320894-2025-00212
• Device Sequence Number: 9089388
• Product Code: MKJ
• UDI-Device Identifier: 10653405042488
• UDI-Public: (01)10653405042488(17)280522(10)Y05222504
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P200004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2025

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: 2001Z-C
• Device Lot Number: Y05222504
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2025
• Supplement Date Received by Manufacturer: 10/07/2025
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2025
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic