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

Catalog Number	2001Z
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	01/30/2026
Type of Reportable Event	Death
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
A sales representative reported on behalf of a customer that the 2001z, adult/child = 10 kg radio transparent electrode,zoll device was used during a cardiac arrest on 30jan26 and ¿pad pro used to resuscitate patient, error came up on zoll unit.Unable to rectify issue.Pads were changed for a different lot and resuscitation was completed successfully.".The procedure was completed with the use of an alternate device.There was no report of injury, medical/surgical intervention, or extended hospitalization for the patient.Further assessment was attempted, and a good faith effort was made to obtain additional information; however, no response has been received to date.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Update: based on information received on 24mar2026, the classification of the mdr has been updated from malfunction to death (b1, b2).The following sections have also been updated: b5, g3, g6, h1, h2, h6, h11.Additional manufacturer narrative update: reported event of the pads having an unrectifiable issue during resuscitation is inconclusive.Per the complaint, the "team at (b)(6) felt that the cable on the pre-connect pad pro may have got damaged in the rush of the resus event." the hazard below applies since there was damage to the product/wire, resulting in an open circuit so that the device could not be used and a delay in therapy where the user had to use an replacement padpro pad.Neither the device nor photographic evidence was provided.Therefore, the reported event can not be verified.A two-year lot history review shows a total of 1 device for this lot number and failure mode.A device history review (dhr) was requested from the manufacturer, and no indication of abnormalities was communicated.A two-year review of complaint history revealed there has been a total of eight reports, regarding ten 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 the following: 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.
Event or Problem Description
A sales representative reported on behalf of a customer that the 2001z, adult/child [?] 10 kg radiotransparent electrode, zoll device was used during a cardiac arrest on (b)(6) 2026 and "pad pro used to resuscitate patient, error came up on zoll unit.Unable to rectify issue.Pads were changed for a different lot and resuscitation was completed successfully." the procedure was completed with the use of an alternate device.There was no report of injury, medical/surgical intervention, or extended hospitalization for the patient.Further assessment was attempted, and a good faith effort was made to obtain additional information; however, no response has been received to date.Update: the customer reported on (b)(6) 2026: "the message appearing on the device was: 'broken circuit".An internal device fault was "ruled out following inspection.A full functional check and pvp were completed on the defibrillator.No internal faults were identified, and the device passed all service checks.".The sales representative reported additional information received from the customer on 24mar2026: "the patient who was resuscitated with zoll defib and conmed pad pro unfortunately passed away following the resus attempt.The resus team at (b)(6) felt that the cable on the pre-connect pad pro may have got damaged in the rush of the resus event.No other issues have been reported as there are 240 zoll defib units in the hospital all with pad pro.The trust felt that this was a one-off incident.".No further information was provided.
Additional Manufacturer Narrative
Neither the device nor photographic evidence was provided.Therefore, the reported event can not be verified.A two-year lot history review shows a total of 1 device for this lot number and failure mode.A device history review (dhr) was requested from the manufacturer, and no indication of abnormalities was communicated.A two-year review of complaint history revealed there has been a total of eight reports, regarding ten 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 0.000003.Per the instructions for use, the user is advised the following: 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.
Event or Problem Description
A sales representative reported on behalf of a customer that the 2001z, adult/child = 10 kg radiotransparent electrode,zoll device was used during a cardiac arrest on 30jan26 and ¿pad pro used to resuscitate patient, error came up on zoll unit.Unable to rectify issue.Pads were changed for a different lot and resuscitation was completed successfully.".The procedure was completed with the use of an alternate device.There was no report of injury, medical/surgical intervention, or extended hospitalization for the patient.Further assessment was attempted, and a good faith effort was made to obtain additional information; however, no response has been received to date.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: PADPRO
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): CONMED UTICA; 525 french rd; utica NY 13502
• Manufacturer (Section G): KATECHO, INC.; 4020 gannett ave.; desmoines IA 50321
• Manufacturer Contact: beth madeline ; 11311 concept blvd; largo, FL 33773 ; 7274708358
• MDR Report Key: 24399923
• Report Number: 1320894-2026-00038
• Device Sequence Number: 18670287
• Product Code: MKJ
• UDI-Device Identifier: 10653405042471
• UDI-Public: (01)10653405042471(17)271126(10)Y11262401
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P200004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 2001Z
• Device Lot Number: Y11262401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2026
• Supplement Date Received by Manufacturer: 02/23/2026; 04/13/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 02/27/2026; 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/26/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic