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

Catalog Number	2516M-PC
Medical Device Problem Code	Failure to Deliver Shock/Stimulation (1133)
Health Effect - Clinical Code	Ventricular Fibrillation (2130)
Date of Event	12/12/2024
Type of Reportable Event	Serious Injury
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.H3 other text: device not yet received.
Event or Problem Description
A distributor reported on behalf of a customer that the 2001m-c, adult/child=10kg radiotranelectrode, physiocontrolquikcombo device was used in a procedure on (b)(6)2024, and "a patient was coding, and the er nurses were using the defibrillator on them and the defib pads malfunctioned.They tried to use two more sets of pads, and they did not work either.The pads not only did not shock the patient, but they did not even register.Thankfully the ambulance was still here, and they were able to borrow pads from them (that worked) and stabilized the patient.¿.Per follow-up assessment, the pads obtained from ems were "plugged into our monitor and worked properly.".The patient's skin had been prepped, the site was clean and dry, with no body hair.The device was inspected before being introduced.There were no folds in the device, it was fully adhered to the patient site, which was at the "right chest left rib".The location of the pad was changed.The impact to the patient was "prolonged defibrillation, pt in vfib extended amount of time".As of (b)(6) 2024, the patient's status is "alive and remains in the hospital".This report is being raised on the basis of injury due to patient experiencing ventricular fibrillation for an extended amount of time during use of the device in a code situation.
Additional Manufacturer Narrative
Correction: the device number originally reported was incorrect, and has been updated in block d.4.Additional information: henry schein device has been identified as concomitant device, and added to block d.10.Additional manufacturer narrative: examination of returned used device 2516m-pc with a multimeter found that there was an electrical current flowing through the device.A two-year lot history review shows a total of 3 devices for this lot number and failure mode.A device history record review 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 six reports, regarding 71 devices, for this device family and failure mode.During this same time frame 3,248,945 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 0.00002.Per the instructions for use, the user is advised to visually examine the pad before placement.Check that adhesive is intact and undamaged.Do not use any damaged pads, replace pads if necessary.Always apply electrodes to flat areas of skin.If possible, avoid folds if skin such as those underneath the breast or those visible on obese individuals.Inadequate pad adhesion can lead to arcing or skin burns.Poor electrode pad-to-patient contact may result in defibrillator alarm, prompt or other indication.Check all electrical and patient connections from the device to the skin.We will continue to monitor per regulatory requirements to help ensure patient safety.
Event or Problem Description
A distributor reported on behalf of a customer that the 2001m-c, adult/child=10kg radiotranelectrode, physiocontrolquikcombo device was used in a procedure on (b)(6)2024, and "a patient was coding, and the er nurses were using the defibrillator on them and the defib pads malfunctioned.They tried to use two more sets of pads, and they did not work either.The pads not only did not shock the patient, but they did not even register.Thankfully the ambulance was still here, and they were able to borrow pads from them (that worked) and stabilized the patient.¿.Per follow-up assessment, the pads obtained from ems were "plugged into our monitor and worked properly.".The patient's skin had been prepped, the site was clean and dry, with no body hair.The device was inspected before being introduced.There were no folds in the device, it was fully adhered to the patient site, which was at the "right chest left rib".The location of the pad was changed.The impact to the patient was "prolonged defibrillation, pt in vfib extended amount of time".As of (b)(6)2024, the patient's status is "alive and remains in the hospital".This report is being raised on the basis of injury due to patient experiencing ventricular fibrillation for an extended amount of time during use of the device in a code situation.Correction: the subject device is the 2516m-pc, defib electrode adult, radiotrans pads w/preconnect, medtronic, not the 2001m-c, adult/child=10kg radiotranelectrode, physiocontrolquikcombo as initially reported.

• 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: 21093780
• Report Number: 1320894-2025-00011
• Device Sequence Number: 21118522
• Product Code: MKJ
• UDI-Device Identifier: 10653405042631
• UDI-Public: (01)10653405042631(17)270617(10)Y06172401
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P200004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2025

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: 2516M-PC
• Device Lot Number: Y06172401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2024
• Supplement Date Received by Manufacturer: 02/12/2025
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 112-7163 HENRY SCHEIN DEFIBRILLATION ELECTRODES.
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Sex: Female
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic