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

Model Number	2001M-PC
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	07/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The sales representative reported on behalf of the customer that the 2001m-pc, padpro:ad;rtrans el/lw,pre-con, quantity of 3, were being used during a defibrillation due to cardiac arrest on (b)(6) 2022 when it was reported, ¿the padpro electrodes did not stick properly to the patient, why they had to be changed several times and delayed the defib.¿ further assessment questioning found that 3 pads were used on the same patient.There was no report of injury or prolonged hospitalization for the patient; however, the user did report that the scenario was ¿life threatening¿ because the pads did not work during a cardiac arrest defibrillation.This report is being raised on the basis of injury due to report of life-threatening scenario where pads did not stick to patient during use.
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.
Additional Manufacturer Narrative
The device is not being returned and no photographic evidence was provided.Therefore, a device malfunction 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.This is the only complaint for this lot number and failure mode within the past two years.(b)(4).Per the instructions for use, the user is advised to ensure that the patient¿s skin is clean and dry, clipping excess hair.Remove any substance from the skin (e.G., lotions, oils, etc.).1) tear open the pouch; 2) using the extended tab of the release liner, remove the release liner from the multifunction electrodes to expose conductive and adhesive areas.(arrow indicates peel location).This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The sales representative reported on behalf of the customer that the 2001m-pc, padpro:ad;rtrans el/lw,pre-con, quantity of 3, were being used during a defibrillation due to cardiac arrest on 5jul22 when it was reported, ¿the padpro electrodes did not stick properly to the patient, why they had to be changed several times and delayed the defib.¿.Further assessment questioning found that 3 pads were used on the same patient.There was no report of injury or prolonged hospitalization for the patient; however, the user did report that the scenario was ¿life threatening¿ because the pads did not work during a cardiac arrest defibrillation.This report is being raised on the basis of injury due to report of life-threatening scenario where pads did not stick to patient during use.

• Brand Name: PADPRO:AD;RTRANS EL/LW,PRE-CON
• 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: 15321192
• Report Number: 1320894-2022-00186
• Device Sequence Number: 5888826
• Product Code: MKJ
• UDI-Device Identifier: 10653405042594
• UDI-Public: (01)10653405042594(17)250425(10)Y04252209
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K014209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2022

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: 04/25/2025
• Device Model Number: 2001M-PC
• Device Catalogue Number: 2001M-PC
• Device Lot Number: Y04252209
• 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: 08/23/2022
• Supplement Date Received by Manufacturer: 09/14/2022
• Initial Report FDA Received Date: 08/30/2022
• Supplement Report FDA Received Date: 10/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic