MAUDE Adverse Event Report: KATECHO INCORPORATED PADPRO DEFIBRILLATION PADS; DEFIB PADS

Catalog Number	2001M-PC
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	06/27/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
Complaint is inconclusive.The device is not being returned and no photograph evidence was provided.Therefore, the reported failure could not 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 were 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.A two-year review of complaint history revealed there has been 3 complaints regarding 4 devices for this device family and failure mode.During the same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed, the rate of failure would be (b)(4).Per the instructions for use, the user is advised the following; misuse 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.Do not open package until just prior to using the electrodes.Do not use if conductive polymer gel is dried out and if the electrodes do not adhere properly to the patient, apply a new pair.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
The customer reported that the padpro 2001m-pc, was used on a patient that eventually passed away.The pads were placed on the patient but never used to deliver shock.The patient underwent 2 separate rounds of cpr, the first lasted for 30 minutes and the second lasted for 45 minutes.The pads were never used to deliver shock to the patient, they were only applied for monitoring.After the patient expired, the pads were removed and under the sternal pad, which the medical staff performed cpr on top of, a severe skin tear was noticed.No treatment was used since the patient passed away.The complainant did state that the padpro defibrillation pads in no way effected the outcome of the patient or had any effect on the patient passing away.Although the padpro pads were not related to the patient expiring, conmed is reporting due to the patient having the padpro defibrilation pads applied, then removed post-mortem.
Additional Manufacturer Narrative
Complaint is inconclusive.The device is not being returned and no photographic evidence was provided.Therefore, the reported failure could not be verified.Correction: complaint is confirmed.The device is not being returned but photographic evidence provided confirmed the reported problem.

• Brand Name: PADPRO DEFIBRILLATION PADS
• Common Device Name: DEFIB PADS
• Manufacturer (Section D): KATECHO INCORPORATED; 2500 bell avenue; des moines IA 50321
• MDR Report Key: 8841973
• Report Number: 1320894-2019-00264
• Device Sequence Number: 18897069
• Product Code: MKJ
• UDI-Device Identifier: 20653405042591
• UDI-Public: (01)20653405042591(17)211030(10)Y10301803
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K014209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2019

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: 10/30/2021
• Device Catalogue Number: 2001M-PC
• Device Lot Number: Y10301803
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/01/2019
• Supplement Date Received by Manufacturer: 07/01/2019
• Initial Report FDA Received Date: 07/30/2019
• Supplement Report FDA Received Date: 09/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 75 YR
• Patient Weight: 67