MAUDE Adverse Event Report: CONMED PADRPO; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Catalog Number	2001M
Medical Device Problem Code	Failure to Conduct (1114)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported device has been returned to conmed; however, the evaluation of the device has not been completed.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 that the 2001m adult/child=10kg radiotrans electrode,physio control quik combo device was being used during a ventricular fibrillation ablation on (b)(6) 2025 when it was reported ¿energy is coming through but not converting the patients.The first incident was on (b)(6) 25 during a ventricular fibrillation ablation; once the hands-off pads did not work the rn used the manual paddles to defibrillate the patient out of vt.The procedure was completed with the use of an alternate device and there was no report of injury, medical intervention or extended hospitalization for the patient or user.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 2001m adult/child=10kg radiotrans electrd, physiocontrolquikcombo device was being used during a ventricular fibrillation ablation on (b)(6) 2025 when it was reported ¿energy is coming through but not converting the patients.The first incident was on (b)(6) 2025 during a ventricular fibrillation ablation; once the hands-off pads did not work the rn used the manual paddles to defibrillate the patient out of vt.The procedure was completed with the use of an alternate device and there was no report of injury, medical intervention or extended hospitalization for the patient or user.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Examination of the returned unused and unopened device 2001m found that when attached to the calm technologies seam2-4 tester and compliance west mega pulse biphasic tester, the device worked as intended and no fault was found.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 3 devices for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of 4 complaints, regarding 5 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 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.Defibrillation current can cause operator or bystander injury.Do not touch patient, or equipment connected to the patient, during defibrillation.Do not conduct chest compressions through the pads.Doing so may cause damage to the pads that could lead to the possibility of arcing and skin burns.After patient movement due to muscle contraction or patient repositioning, press pads to skin to ensure good coupling between pads and skin.Do not discharge hand-held paddles through these multifunction electrodes.Do not allow pads to touch each other or other ecg monitoring electrodes, lead wires, dressings, etc.We will continue to monitor per regulatory requirements to help ensure patient safety.

• Brand Name: PADRPO
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): CONMED; 525 french rd; utica NY 13502
• Manufacturer (Section G): KATECHO, INC.; 4020 gannett ave; desmoines IA 50321
• Manufacturer Contact: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 23826991
• Report Number: 1320894-2025-00284
• Device Sequence Number: 13000524
• Product Code: MKJ
• UDI-Device Identifier: 10653405042570
• UDI-Public: (01)10653405042570(17)280912(10)Y09122509
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P200004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2026

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: 2001M
• Device Lot Number: Y09122509
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2025
• Supplement Date Received by Manufacturer: 12/31/2025
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic