MAUDE Adverse Event Report: KATECHO INCORPORATED PADPRO DEFIBRILLATION PADS

Catalog Number	2001M-C
Medical Device Problem Codes	Therapeutic or Diagnostic Output Failure (3023); No Pacing (3268); No Visual Prompts/Feedback (4021)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The report device is not being returned to conmed for evaluation, however investigation is still on-going.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.
Event or Problem Description
The customer reported the 2001m-c, pad pro was defective and not working during use.Further clarification was received.It was stated that during a code, the staff hooked up the pads and machine.They got no reading.They tried another machine, still had no readings.They changed the pads using another of the same pad but different lot number and it worked.There was no patient injury or impact reported.This report is being raised based on device malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
The device will not be returned for evaluation and no photographic evidence was provided therefore root cause cannot be identified.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.(b)(4).Per the instructions for use, the user is advised the following; to make sure the skin is dry i.E.Free of water, sweat, alcohol, etc.Do not apply any substance to the skin surface that will leave a residue, i.E.Lotions, oils, etc.Do not fold, trim, crush, or store under heavy objects.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.A determination for further investigation has been initiated.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: PADPRO DEFIBRILLATION PADS
• Common Device Name: DEFIBRILLATION PADS
• Manufacturer (Section D): KATECHO INCORPORATED; 2500 bell avenue; des moines IA 50321
• MDR Report Key: 9136513
• Report Number: 1320894-2019-00328
• Device Sequence Number: 19289019
• Product Code: MKJ
• UDI-Device Identifier: 20653405042584
• UDI-Public: (01)20653405042584(17)220301(10)Y03011907
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K014209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/01/2022
• Device Catalogue Number: 2001M-C
• Device Lot Number: Y03011907
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/03/2019
• Supplement Date Received by Manufacturer: 10/09/2019
• Initial Report FDA Received Date: 09/30/2019
• Supplement Report FDA Received Date: 10/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1