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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	09/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The distributor reported on behalf on their customer that the 2001z-c, padpro:zoll dc;transparent-l/ws, 12x7, 10/cs device was being used during an outpatient cardioversion procedure on (b)(6) 2023 when it was reported ¿a patient was burned by material.¿.Further assessment questioning found that the patient was diagnosed with an unknown degree of burn and was treated with silvadine cream.The procedure was completed with an unknown amount of delay.The current status of the patient was reported as ¿no additional follow up¿.There was no report extended hospitalization for the patient or user.This report is being raised on the reported injury due to patient being diagnosed with unknown degree of burn.
Additional Manufacturer Narrative
The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.We will continue to monitor for trends through the complaint system to assure patient safety.H3 other text : device not yet received.
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.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.A two-year lot history review shows a total of 2 devices for this lot number and failure mode.(b)(4).Per the instructions for use, the user is advised to visually examine the pad before placement.Check that the adhesive is intact and undamaged.Do not use any damaged pads, replace pads if necessary.Apply the multifunction electrodes to the patient, in accordance with your institution¿s protocol, by firmly rolling the electrode from top to bottom.Ensure that the total surface area of the electrode is in contact with the prepared skin.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
The distributor reported on behalf on their customer that the 2001z-c, padpro:zoll dc;transparent-l/ws, 12x7, 10/cs device was being used during an outpatient cardioversion procedure on (b)(6) 2023 when it was reported ¿a patient was burned by material.¿.Further assessment questioning found that the patient was diagnosed with an unknown degree of burn and was treated with silvadine cream.The procedure was completed with an unknown amount of delay.The current status of the patient was reported as ¿no additional follow up¿.There was no report extended hospitalization for the patient or user.This report is being raised on the reported injury due to patient being diagnosed with unknown degree of burn.

• 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 monies IA 50321
• Manufacturer (Section G): KATECHO,INC.; 4020 gannett avenue; des monies IA 50321
• Manufacturer Contact: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 17964170
• Report Number: 1320894-2023-00222
• Device Sequence Number: 7623193
• Product Code: MKJ
• UDI-Device Identifier: 10653405042488
• UDI-Public: (01)10653405042488(17)260728(10)Y07282305
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P200004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/28/2026
• Device Catalogue Number: 2001Z-C
• Device Lot Number: Y07282305
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2023
• Supplement Date Received by Manufacturer: 12/07/2023
• Initial Report FDA Received Date: 10/19/2023
• Supplement Report FDA Received Date: 12/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic