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

Catalog Number	2001M-C
Medical Device Problem Code	Failure to Deliver Shock/Stimulation (1133)
Health Effect - Clinical Codes	Arrhythmia (1721); Burn(s) (1757)
Date of Event	08/14/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
Note: reporter did not know what lot number was initially used on patient.Secondary lot number reported: y01312501 manufacturer narrative: the reported device has been returned to conmed; however, the complaint investigation has not been completed.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
The customer reported that the device, 2001m-c, adult/child=10kg radiotranelectrode, physiocontrolquikcombo, was being used during a resuscitation procedure on (b)(6) 2025 when it was reported, ¿defibrillator pads burned/smoking.Scalded patient and failed to defibrillate.Replaced pads and functioned correctly.2 lots used, unsure as to which lot had issue.Patient status deceased.¿.Further assessment found that this was a resuscitation event.The burn was discovered immediately after pulling back the gown during the event.The burn was not evaluated as the patient was deceased.The burn occurred on the chest/upper abdomen.The reporter has stated that after defibrillation "we had return of spontaneous circulation briefly." as for a connection between device and patient death, reporter stated they are "unsure" and added, "we were unable to resuscitate this patient in a timely manner.The patient was in a shockable arrhythmia, hence why defibrillation was used.If we would have been able to shock the patient out of the rhythm sooner, it may have changed the outcome of the resuscitation event, but that is speculative, and i cannot specifically say that this would have changed the outcome." the first set of pads had 7 defibrillations used while cpr was being performed on the patient.It is likely that patient movement was occurring.This report is being raised due to advisement of patient death.
Additional Manufacturer Narrative
Note: reporter did not know what lot number was initially used on patient.Secondary lot number reported: y01312501.Manufacturer narrative: an examination of the returned used device 2001m-c found that there were burn marks on the pad connected to the white cord.There was also burn marks on the cord itself.Could not confirm the lot number as they sent two different packages with different lot numbers and only one device was returned.Root cause cannot be determined, however, based upon evaluation of the device, review of ifu; a possible cause of this event could be failure to follow product instructions may result in patient burns.A device history record (dhr) review found no abnormalities that would contribute to this reported event.(b)(4).Per the instructions for use, the user is advised to 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.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
The customer reported that the device, 2001m-c, adult/child: 10kg.Radiotranelectrode, physiocontrolquikcombo, was being used during a resuscitation procedure on (b)(6) 2025 when it was reported, ¿defibrillator pads burned/smoking.Scalded patient and failed to defibrillate.Replaced pads and functioned correctly.2 lots used, unsure as to which lot had issue.Patient status deceased.¿.Further assessment found that this was a resuscitation event.The burn was discovered immediately after pulling back the gown during the event.The burn was not evaluated as the patient was deceased.The burn occurred on the chest/upper abdomen.The reporter has stated that after defibrillation "we had return of spontaneous circulation briefly." as for a connection between device and patient death, reporter stated they are "unsure" and added, "we were unable to resuscitate this patient in a timely manner.The patient was in a shockable arrhythmia, hence why defibrillation was used.If we would have been able to shock the patient out of the rhythm sooner, it may have changed the outcome of the resuscitation event, but that is speculative, and i cannot specifically say that this would have changed the outcome." the first set of pads had 7 defibrillations used while cpr was being performed on the patient.It is likely that patient movement was occurring.This report is being raised due to advisement of patient death.

• 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: 23053740
• Report Number: 1320894-2025-00225
• Device Sequence Number: 12916113
• Product Code: MKJ
• UDI-Device Identifier: 10653405042587
• UDI-Public: (01)10653405042587(17)270607(10)Y06072403
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2025

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: 2001M-C
• Device Lot Number: Y06072403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2025
• Supplement Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 09/15/2025
• Supplement Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2001M-C, ADULT/CHILD: 10KG RADIOTRANELECTRODE; 2001M-C, ADULT/CHILD: 10KG RADIOTRANELECTRODE
• Outcome Attributed to Adverse Event: Death
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic