MAUDE Adverse Event Report: KATECHO, INC. PADPRO:AD;RTRANS EL/LW, 12X7; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Catalog Number 2001M-C

Device Problem Fire (1245)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 01/22/2024

Event Type  malfunction  

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 for trends through the complaint system to assure patient safety.

Event Description

The sales representative reported on behalf of the customer that the 2001m-c, padpro:ad;rtrans el/lw, 12x7 device was being used on (b)(6) 2024 during a synchronized cardioversion and ¿defibrillator pads caught fire when shock was delivered 200j shock.The defibrillator used was a lifepak 20¿.Follow-up assessment indicated: "there were visible flames around the perimeter of the pad".The reporter further indicated that the patient's site was dry at the time the pad was introduced; the patient had body hair where the pad was introduced; and "the hair was removed for both the anterior and posterior site using surgical clippers." the device was inspected prior to patient usage; there were no folds in the device; the pad was adhered in full to the patient's skin; it was the first application of the pad; and the pad remained in place for 30 minutes.The patient "sustained a 'mild dermatitis/superficial burn' to chest.- physician note", and received "petrolatum applied twice daily".The patient had an "extended stay unrelated to this occurrence" and was "discharged to home".This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

The device will not be returned, and no photographic evidence was provided.Therefore, a device malfunction 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 this is the only event for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of (b)(4) reports, regarding (b)(4) devices, for this device family and failure mode.During this same time frame (b)(4) 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.Defibrillation current can cause operator or bystander injury.Do not touch patient, or equipment connected to the patient, during defibrillation.Do 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.Do not use if packaging appears to be compromised.Damaged packaging may cause the conductive polymer gel to dry out.Do not use multifunction electrodes in the presence of flammable agents or in an oxygen enriched atmosphere as this presents an explosion and fire hazard.We will continue to monitor for trends through the complaint system to assure patient safety.

Event Description

The sales representative reported on behalf of the customer that the 2001m-c, padpro:ad;rtrans el/lw, 12x7 device was being used on (b)(6) 2024 during a synchronized cardioversion and ¿defibrillator pads caught fire when shock was delivered 200j shock.The defibrillator used was a lifepak 20¿.Follow-up assessment indicated: "there were visible flames around the perimeter of the pad".The reporter further indicated that the patient's site was dry at the time the pad was introduced; the patient had body hair where the pad was introduced; and "the hair was removed for both the anterior and posterior site using surgical clippers." the device was inspected prior to patient usage; there were no folds in the device; the pad was adhered in full to the patient's skin; it was the first application of the pad; and the pad remained in place for 30 minutes.The patient "sustained a 'mild dermatitis/superficial burn' to chest.- physician note", and received "petrolatum applied twice daily".The patient had an "extended stay unrelated to this occurrence" and was "discharged to home".This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

• Brand Name: PADPRO:AD;RTRANS EL/LW, 12X7
• Type of Device: 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: 18734100
• MDR Text Key: 335691289
• Report Number: 1320894-2024-00036
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P200004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2001M-C
• Device Lot Number: Y11082302
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2023
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic