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

Catalog Number	2001Z-C
Medical Device Problem Code	Failure to Read Input Signal (1581)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported two lot numbers used in the event, y05302509 and y05222504.It is uncertain which lot number was at issue.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 customer reported that the 2001z-c, adult/child = 10 kg radiotransparent electrode, zoll device was used in a cardioversion procedure on (b)(6) 2025, and ¿in the emergency room the patient received a cardioversion.Needed to switch out pads to complete procedure.(b)(6) remained 5 additional days in hospital.Delayed pushing meds, patient care, and cardioversion.No direct injury or adverse effect of pads.Pt stayed as an inpatient for 6 days after receiving the cardioversion, then left heart cath, then ppm implantation¿.The procedure was completed with an alternate device with a delay of 3 to 5 minutes.Further assessment found the "pads were not reading a rhythm" and "when the pads were not reading the rhythm, they were not used for shocking the patient- they were removed and a new set was used.".This was the first application of the pads and they were fully adherent to the patient's skin.The patient¿s status is reported as ¿discharged from inpatient status.¿.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Event or Problem Description
A customer reported that the 2001z-c, adult/child = 10 kg radiotransparent electrode, zoll device was used in a cardioversion procedure on (b)(6) 2025, and ¿in the emergency room the patient received a cardioversion.Needed to switch out pads to complete procedure.Pat remained 5 additional days in hospital.Delayed pushing meds, patient care, and cardioversion.No direct injury or adverse effect of pads.Pt stayed as an inpatient for 6 days after receiveing the cardioversion, then left heart cath, then ppm implantation¿.The procedure was completed with an alternate device with a delay of 3 to 5 minutes.Further assessment found the "pads were not reading a rhythm" and "when the pads were not reading the rhythm, they were not used for shocking the patient- they were removed and a new set was used.".This was the first application of the pads and they were fully adherent to the patient's skin.The patient¿s status is reported as ¿discharged from inpatient status.¿.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The customer reported two lot numbers used in the event, y05302509 and y05222504.It is uncertain which lot number was at issue.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 three reports, regarding five 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.Warning: do not use padpro® mfes with any model of defibrillator or therapy cables that are not listed [in the instructions for use].Defibrillator models that are not listed have not been qualified for use with conmed mfes and mfe performance may be impacted.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: beth madeline ; 11311 concept blvd; largo, FL 33773 ; 7274708358
• MDR Report Key: 23165345
• Report Number: 1320894-2025-00233
• Device Sequence Number: 9613084
• Product Code: MKJ
• UDI-Device Identifier: 10653405042488
• UDI-Public: (01)10653405042488(17)280530(10)Y05302509
• 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
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2025

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: Y05302509
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2025
• Supplement Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 09/29/2025
• Supplement Report FDA Received Date: 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic