MAUDE Adverse Event Report: KATECHO, INC. PADPRO:ZOLL DC;TRANSPARENT-L/WS, 12X7, 10/CS; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Catalog Number	2001Z-C
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Codes	Burn(s) (1757); Skin Tears (2516)
Date of Event	04/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The sales representative reported on behalf of the customer that the 2001z-c, padpro:zoll dc;transparent-l/ws, 12x7, 10/cs was being used on approximately (b)(6) 2024 and a ¿70/m in the ed undergoing cardioversion for afib.His chest was shaved and no gel or moisture was present.When the patient was shocked at 200 j, a pop was heard and the smell of singed skin was detectable in the air.The patient had some small areas of skin that were reddened and came off with the pads when they were removed.¿ the procedure was completed and there was a ¿mild burn along edge of pad¿.This report is being raised due to the reported injury of skin removed and burn of unknown degree.
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.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer that the 2001z-c, padpro:zoll dc;transparent-l/ws, 12x7, 10/cs was being used on approximately (b)(6) 2024 and a ¿70/m in the ed undergoing cardioversion for afib.His chest was shaved and no gel or moisture was present.When the patient was shocked at 200 j, a pop was heard and the smell of singed skin was detectable in the air.The patient had some small areas of skin that were reddened and came off with the pads when they were removed.¿ the procedure was completed and there was a ¿mild burn along edge of pad¿.This report is being raised due to the reported injury of skin removed and burn of unknown degree.
Additional Manufacturer Narrative
The device has not been returned to date and no photographic evidence has been provided; therefore, the reported event cannot be verified.A two-year lot history review shows a total of 1 device for this lot number and failure mode.A device history record (dhr) 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 10 reports, regarding 10 devices, for this device family and failure mode.(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.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 or Problem Description
The sales representative reported on behalf of the customer that the 2001z-c, padpro:zoll dc;transparent-l/ws, 12x7, 10/cs was being used on approximately (b)(6) 2024 and a ¿70/m in the ed undergoing cardioversion for afib.His chest was shaved and no gel or moisture was present.When the patient was shocked at 200 j, a pop was heard and the smell of singed skin was detectable in the air.The patient had some small areas of skin that were reddened and came off with the pads when they were removed.¿ the procedure was completed and there was a ¿mild burn along edge of pad¿.Further assessment was sent; however, no additional information has been received.This report is being raised due to the reported injury of skin removed and burn of unknown degree.
Additional Manufacturer Narrative
Update: reported event of ¿mild burn along edge of pad¿ is unconfirmed.Received fifteen 2001z-c in unopened original packaging.Lot number was verified.Performed a visual inspection, there were no obvious signs of abnormalities or defects.Performed a functional inspection using the meterman 30xr (c2551), the pads had continuity.A two-year lot history review shows a total of 1 device for this lot number and failure mode.A device history record (dhr) review was requested from the manufacturer, and no indication of abnormalities was communicated.(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.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.

• Brand Name: PADPRO:ZOLL DC;TRANSPARENT-L/WS, 12X7, 10/CS
• 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: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 19323322
• Report Number: 1320894-2024-00133
• Device Sequence Number: 7577427
• Product Code: MKJ
• UDI-Device Identifier: 10653405042488
• UDI-Public: (01)10653405042488(17)260915(10)Y09152301
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/10/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/15/2026
• Device Catalogue Number: 2001Z-C
• Device Lot Number: Y09152301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2024
• Supplement Date Received by Manufacturer: 06/07/2024; 07/03/2024
• Initial Report FDA Received Date: 05/15/2024
• Supplement Report FDA Received Date: 06/11/2024; 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic