MAUDE Adverse Event Report: KATECHO INCORPORATED PADPRO DEFIB. PADS

Catalog Number 2001Z

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Superficial (First Degree) Burn (2685); Partial thickness (Second Degree) Burn (2694)

Event Date 10/30/2018

Event Type  Injury  

Manufacturer Narrative

The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The customer reported that the 2001z, pad pro defibrillation pads caused aa alleged 1st to 2nd degree burn on a patient.This occurred while administering an external elective synchronized cardioversion on (b)(6) 2018.The pads were placed on the right anterior chest and the posterior scapula.The burns were photographed and provided to conmed.The burn was on the anterior pad placement around the gel area, not in the gel area.The patient was treated with silvadene lotion and released home.There was no delay in the surgery and no prolonged hospitalization.Further information was requested but to date no other information was available.There is no further patient status as he/she has not returned to the physician to date.This report is being raised based on patient injury.

Manufacturer Narrative

Previously stated "the customer reported that the 2001z, pad pro defibrillation pads caused an alleged 1st to 2nd degree burn on a patient.This occurred while administering an external elective synchronized cardioversion on october 30th, 2018.The pads were placed on the right anterior chest and the posterior scapula.The burns were photographed and provided to conmed.The burn was on the anterior pad placement around the gel area, not in the gel area.The patient was treated with silvadene lotion and released home.There was no delay in the surgery and no prolonged hospitalization.Further information was requested but to date no other information was available.There is no further patient status as he/she has not returned to the physician to date" changed to current b5 summary evaluation findings: one 2001z was received in opened original packaging, the reported catalog and lot numbers were verified.The pads were adhered to each other upon arrival.Visual inspection did not find any evidence of burn marks on the pads however two indentations were observed in the foam of one of the pads.Visual inspection also found many hairs that were adhered to the pads.Continuity was tested through both and checked at multiple different locations (corners, outer area, and inner area) using a digital multimeter.Both pads passed continuity testing.Review of the photographs of the patient provided by the user facility shows redness around the location of the electrode pad; based upon the evaluation and the photographic evidence, the redness of the skin appears to be a sensitivity reaction to the electrode pad rather than a burn.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 a total of 3 complaints, regarding 3 devices for this device family and failure mode.During this same time frame 1,966,190 devices were manufactured and shipped worldwide.Should all the complaint devices have been found confirmed the rate of failure would be.000002 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,.

Event Description

Corrected data: the customer reported that the 2001z, pad pro defibrillation pads caused an alleged 1st to 2nd degree burn on a patient.This occurred while administering an external elective synchronized cardioversion on (b)(6) 2018.The pads were placed on the right anterior chest and the posterior scapula.The burns were photographed and provided to conmed.The burn was on the anterior pad placement around the gel area, not in the gel area.Based on the photographic evidence, this appears to be more of a skin reaction, not an "alleged" burn.A burn would appear in the gel area, not on the edges of the pad, this is more indicative of an adhesive reaction to the skin.The patient was treated with silvadene lotion, an over the counter medication and released home.There was no delay in the surgery and no prolonged hospitalization.Further information was requested but to date no other information was available.There is no further patient status as he/she has not returned to the physician to date.A medwatch was received it states the patient received 2nd-3rd degree burns.However, the photographs do not support this claim.There are no indications of blistering or skin breakdown.

• Brand Name: PADPRO DEFIB. PADS
• Type of Device: DEFIB. PADS
• Manufacturer (Section D): KATECHO INCORPORATED; 2500 bell avenue; des moines IA 50321
• MDR Report Key: 8088680
• MDR Text Key: 127857470
• Report Number: 1320894-2018-00251
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• PMA/PMN Number: K014209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 12/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/12/2020
• Device Catalogue Number: 2001Z
• Device Lot Number: Y12121708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2018
• Date Manufacturer Received: 11/20/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Other