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

Model Number	2001M-C
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the device, 2001m-c, padpro:ad;rtrans el/lw, 12x7, was being used during a cardioversion on (b)(6) 2022 when it was reported ¿patient experiencing redness in shape and location of the defib pads after bedside cardioversion.Patient states the redness felt like a sunburn.¿.The reporter advised that there was no formal diagnosis of the ¿burn¿ and there was no report of malfunction of the device.The procedure was reported as having been completed.There was no report of injury, medical intervention, or hospitalization for the patient.The patient was discharged and advised to contact the nurse manager if the condition worsened or did not subside in 1-2 days.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional 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.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The customer reported that the device, 2001m-c, padpro:ad;rtrans el/lw, 12x7, was being used during a cardioversion on 3mar22 when it was reported ¿patient experiencing redness in shape and location of the defib pads after bedside cardioversion.Patient states the redness felt like a sunburn.¿.The reporter advised that there was no formal diagnosis of the ¿burn¿ and there was no report of malfunction of the device.The procedure was reported as having been completed.There was no report of injury, medical intervention, or hospitalization for the patient.The patient was discharged and advised to contact the nurse manager if the condition worsened or did not subside in 1-2 days.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The device is not being returned and no photograph evidence was provided.Therefore, the reported failure could not be verified.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of 12 complaints, regarding 13 devices, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.(b)(4).Per the instructions for use, the user is advised that electrode must be used before date indicated on package.Do not open package until immediately prior to use.Dried conductive polymer gel can lead to skin irritation or burns and can potentially impact mfe performance.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: PADPRO:AD;RTRANS EL/LW, 12X7
• 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: 13789000
• Report Number: 1320894-2022-00060
• Device Sequence Number: 19261154
• Product Code: MKJ
• UDI-Device Identifier: 10653405042587
• UDI-Public: (01)10653405042587(17)241201(10)Y12012107
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K014209
• 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): 04/26/2022

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 Expiration Date: 12/01/2024
• Device Model Number: 2001M-C
• Device Catalogue Number: 2001M-C
• Device Lot Number: Y12012107
• 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: 03/04/2022
• Supplement Date Received by Manufacturer: 03/22/2022
• Initial Report FDA Received Date: 03/16/2022
• Supplement Report FDA Received Date: 04/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 80 KG
• Patient Ethnicity: Non Hispanic