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

Catalog Number	2516M
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The sales representative reported on behalf of the customer that the device, 2516m, defib electrode adult, radiotranslucent pads, medtronic conn, was being used during an unknown emergency procedure on (b)(6) 2024 when it was reported, ¿last night, the munster icu staff encountered issues with the hands-off pads.When the staff opened the package to place them on the patient during an emergency, the gel that is attached to them was sticking to the paper that peels off instead of staying on the pad making them unusable.Staff opened multiple packs with the same issue.This is a safety concern as these pads are used as a pacemaker and to defibrillate during a code blue.The packs were not expired.The one that is left in the unit does not expire until 2027.I tried some that are a different lot number and had no issues.I pulled the ones with the same lot number as below.It appears to be isolated to that particular lot number.".There was no report of injury, medical intervention, or hospitalization for the patient.Further information has been requested; however, to date no further information has been received.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
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.
Additional Manufacturer Narrative
Correction: due to new information, the facility location has been updated.Manufacturer narrative: the device is not being returned and the photographic evidence provided does not appear to verify the complaint; therefore, the reported event cannot be verified.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 one (1) device for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of one complaint, regarding one device, 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.
Event or Problem Description
The sales representative reported on behalf of the customer that the device, 2516m, defib electrode adult, radiotranslucent pads, medtronic conn, was being used during an unknown emergency procedure on (b)(6) 2024 when it was reported, ¿last night, the munster icu staff encountered issues with the hands-off pads.When the staff opened the package to place them on the patient during an emergency, the gel that is attached to them was sticking to the paper that peels off instead of staying on the pad making them unusable.Staff opened multiple packs with the same issue.This is a safety concern as these pads are used as a pacemaker and to defibrillate during a code blue.The packs were not expired.The one that is left in the unit does not expire until 2027.I tried some that are a different lot number and had no issues.I pulled the ones with the same lot number as below.It appears to be isolated to that particular lot number.".There was no report of injury, medical intervention, or hospitalization for the patient.Further information has been requested; however, to date no further information has been received.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

• 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: 21065896
• Report Number: 1320894-2025-00003
• Device Sequence Number: 11617446
• Product Code: MKJ
• UDI-Device Identifier: 10653405042624
• UDI-Public: (01)10653405042624(17)270920(10)Y09202409
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2025

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: Y09202409
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2024
• Supplement Date Received by Manufacturer: 01/29/2025
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic