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	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	09/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The distributor reported on behalf of their customer that the 2001z-c, padpro:zoll dc;transparent-l/ws, 12x7, 10/cs was being used during an unknown procedure on (b)(6) 2023 when it was reported ¿burned patient.Unknown area.No permanent damage¿.Further assessment answers were requested of the reporter and a good faith effort was completed; however, the reporter has not responded to our attempts for information.There was no report of medical intervention, or extended hospitalization for the patient or user.This report is being raised on the reported injury due to patient obtaining an unknown degree of burn.
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.
Additional Manufacturer Narrative
The device will not be returned, and no photographic evidence was provided.Therefore, the reported event cannot be verified.A device history record review was requested from the manufacturer, and no indication of abnormalities were communicated.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 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.Conmed encourages the inspection and/or testing of all medical equipment, labeling, and packaging prior to use.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
The distributor reported on behalf of their customer that the 2001z-c, padpro:zoll dc;transparent-l/ws, 12x7, 10/cs was being used during an unknown procedure on (b)(6) 2023 when it was reported ¿burned patient.Unknown area.No permanent damage¿.There was no report of medical intervention, or extended hospitalization for the patient or user.This report is being raised on the reported injury due to patient obtaining an 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: 17959471
• Report Number: 1320894-2023-00218
• Device Sequence Number: 7044249
• Product Code: MKJ
• UDI-Device Identifier: 10653405042488
• UDI-Public: (01)10653405042488(17)260728(10)Y07282305
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 12/06/2023

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: 11/07/2023
• Initial Report FDA Received Date: 10/18/2023
• Supplement Report FDA Received Date: 12/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic