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

Model Number	2001Z-C
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	10/29/2022
Type of Reportable Event	Death
Event or Problem Description
This complaint was created due to the receipt of a medwatch report ((b)(4)) on 27mar23.The current complaint database has been researched for this event and there were no findings.The report was found to be written against 2001z-c, padpro:zoll dc;transparent-l/ws, 12x7, 10/cs, that was being used during a code procedure in the critical care unit that occurred on (b)(6) 2022.The report stated ¿elderly patient had a sudden decrease in oxygen levels and level of consciousness.A code was called and advanced cardiac life support (acls) was started.During the first defibrillation attempt, sparks and a smoke smell were noted.There was no apparent harm to the patient from the spark event.The defibrillator pads were adjusted for better skin adherence and a subsequent defibrillation attempt was performed successfully without problems.Return of spontaneous circulation was achieved with a weak, thready pulse and hypotension.The best explanation is the pads were not fully adhered to the patient¿s skin, likely due to the hurriedness of the situation, contributing to the spark and smoke.The pads were adjusted for better adherence and a subsequent defibrillation attempt did not have problems.¿.After further assessment, it was reported that the patient did not acquire a burn.However, it was noted the patient died an hour after the code event and it was said to be unrelated to the defibrillator pad incident.The patient had preexisting medical conditions that may have contributed to the event.Death was reported, medical intervention took place in the critical care unit, and further hospitalization was not needed because the patient is deceased.This report is being raised on the basis of death however, the information indicated the patient is deceased but not as a result of the pad incident.
Additional Manufacturer Narrative
The reported device is not 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.
Additional Manufacturer Narrative
Correction: b.5.27mar23 to 27feb23 reported event of ¿sparks and a smoke smell were noted¿ was inconclusive.The device will not be returned, and no photographic evidence was provided.Therefore, a device malfunction cannot be verified.A two-year lot history review cannot be conducted as a lot number was not provided.The manufacturing documents from the device history record could not be conducted as a lot number was not provided.A two-year review of complaint history revealed there has been a total of 16 reports, regarding 17 devices, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be (b)(4).Per the instructions for use, the user is advised the following: the user is advised to visually examine the pad before placement.Check that 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.Inadequate pad adhesion can lead to arcing or skin burns.Do not reposition electrodes.Replace with new electrodes if necessary.We will continue to monitor for trends through the complaint system to assure patient safety.
Event or Problem Description
This complaint was created due to the receipt of a medwatch report (b)(4) on 27feb23.The current complaint database has been researched for this event and there were no findings.The report was found to be written against 2001z-c, padpro:zoll dc;transparent-l/ws, 12x7, 10/cs, that was being used during a code procedure in the critical care unit that occurred on (b)(6) 2022.The report stated ¿elderly patient had a sudden decrease in oxygen levels and level of consciousness.A code was called and advanced cardiac life support (acls) was started.During the first defibrillation attempt, sparks and a smoke smell were noted.There was no apparent harm to the patient from the spark event.The defibrillator pads were adjusted for better skin adherence and a subsequent defibrillation attempt was performed successfully without problems.Return of spontaneous circulation was achieved with a weak, thready pulse and hypotension.The best explanation is the pads were not fully adhered to the patient¿s skin, likely due to the hurriedness of the situation, contributing to the spark and smoke.The pads were adjusted for better adherence and a subsequent defibrillation attempt did not have problems.¿.After further assessment, it was reported that the patient did not acquire a burn.However, it was noted the patient died an hour after the code event and it was said to be unrelated to the defibrillator pad incident.The patient had preexisting medical conditions that may have contributed to the event.Death was reported, medical intervention took place in the critical care unit, and further hospitalization was not needed because the patient is deceased.This report is being raised on the basis of death however, the information indicated the patient is deceased but not as a result of the pad incident.

• 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 moines IA 50321
• Manufacturer Contact: aubrey nardozzi ; 11311 concept blvd; largo, FL 33773 ; 7273995288
• MDR Report Key: 16620392
• Report Number: 1320894-2023-00059
• Device Sequence Number: 6193822
• Product Code: MKJ
• UDI-Device Identifier: 10653405042488
• UDI-Public: (01)10653405042488
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2023

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 Model Number: 2001Z-C
• Device Catalogue Number: 2001Z-C
• Device Lot Number: UNKNOWN
• 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: 02/27/2023
• Supplement Date Received by Manufacturer: 04/13/2023
• Initial Report FDA Received Date: 03/27/2023
• Supplement Report FDA Received Date: 04/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic