MAUDE Adverse Event Report: KATECHO, INC. PADPRO:AD;RADIOTRANSLUCENT EL, 12X7, 10/CS; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Catalog Number 2516Z

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 03/31/2023

Event Type  Injury  

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 2516z, padpro:ad; radiotranslucent el, 12x7, 10/cs, was being used during a coronary artery bypass procedure on (b)(6) 2023 when it was reported, ¿a patient developed a burn like lesion on his right side of the chest, several days after the product was placed on the patient.Patient was never shocked.¿ further assessment questioning found ¿currently presents as burn, partial thickness; possibly medical device related."¿"60-year-old male with right chest burn that appears to be second-degree from cautery injury incidentally.¿ medical intervention that was performed and current patient status is reported as, ¿right chest: cleanse with normal saline.Apply adaptic to wound bed and cover with mepilex border foam dressing.Change m/w/f and prn.Current status, burn plan, recommend bacitracin with xeroform and abd daily, more if needed, wound care team following, burn surgery will continue to follow along.¿ patient discharged home.It should be noted that there has not been a malfunction of the device reported and the reporter stated that the patient was never shocked using the device.This report is being raised due to the reported injury for diagnosis of 2nd degree burn to patient.

Manufacturer Narrative

The device will not be returned for evaluation and no photographic evidence has been provided; therefore, the reported event cannot be verified.The manufacturing documents from the device history record have not been reviewed because the lot number is not known.The lot history review was not conducted because the lot number is not known.A two-year review of complaint history revealed there has been a total of 15 complaints, regarding 16 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 the following: 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.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 2516z, padpro:ad;radiotranslucent el, 12x7, 10/cs, was being used during a coronary artery bypass procedure on (b)(6) 2023 when it was reported, ¿a patient developed a burn like lesion on his right side of the chest, several days after the product was placed on the patient.Patient was never shocked.¿.Further assessment questioning found ¿currently presents as burn, partial thickness; possibly medical device related." "60-year-old male with right chest burn that appears to be second-degree from cautery injury incidentally.¿ medical intervention that was performed and current patient status is reported as, ¿right chest: cleanse with normal saline.Apply adaptic to wound bed and cover with mepilex border foam dressing.Change m/w/f and prn.Current status, burn plan, recommend bacitracin with xeroform and abd daily, more if needed, wound care team following, burn surgery will continue to follow along.¿ patient discharged home.It should be noted that there has not been a malfunction of the device reported and the reporter stated that the patient was never shocked using the device.This report is being raised due to the reported injury for diagnosis of 2nd degree burn to patient.

• Brand Name: PADPRO:AD;RADIOTRANSLUCENT EL, 12X7, 10/CS
• 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: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 17085331
• MDR Text Key: 316845976
• Report Number: 1320894-2023-00112
• 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: 07/14/2023

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 2516Z
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/23/2023
• Initial Date FDA Received: 06/08/2023
• Supplement Dates Manufacturer Received: 06/19/2023
• Supplement Dates FDA Received: 07/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 62 KG
• Patient Ethnicity: Non Hispanic