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

Catalog Number 2001Z

Device Problem Unintended Electrical Shock (4018)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

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.We will continue to monitor for trends through the complaint system to assure patient safety.

Event Description

The customer reported that the device, 2001z, padpro p/c dc transparent zoll, 12x7, 10/cs, was being used during a cardioversion procedure on an unknown date when it was reported, ¿received a complaint from our nic department after recent switch from (name) brand pads to conmed that "all the doctors over here are complaining- several patients having to receive multiple shocks for cardioversion, the do not adhere very well to the patients causing more fear of arcing etc, and we are now noticing multiple shocks on patients.¿.There was no report of injury, medical intervention, or hospitalization for the patient.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

The device will not be returned for evaluation and no photographic evidence has been provided; therefore, the reported event cannot be verified.The device history record was not reviewed because the lot number is not known.The lot history review was not conducted because the lot number is not known.A two-year review of complaint history revealed there has been a total of 10 complaints, regarding 12 devices, for this device family and failure mode.During this same time frame 2,699,510 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 0.000004.Per the instructions for use, the user is advised the following: electrodes must be used before date indicated on package.Do not open package until immediately prior to use.Dried conductive polymer gel can lead to skin irritation or burns and can potentially impact mfe performance.Preparation: ensure that the patient¿s skin is clean and dry, clipping excess hair.Remove any substances from the skin (e.G.Lotions, oils, etc.).Tear open the pouch.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.) warning: 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 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.We will continue to monitor for trends through the complaint system to assure patient safety.

Event Description

The customer reported that the device, 2001z, padpro p/c dc transparent zoll, 12x7, 10/cs, was being used during a cardioversion procedure on an unknown date when it was reported, ¿received a complaint from our nic department after recent switch from (name) brand pads to conmed that "all the doctors over here are complaining- several patients having to receive multiple shocks for cardioversion, the do not adhere very well to the patients causing more fear of arcing etc¿.And we are now noticing multiple shocks on patients.¿.There was no report of injury, medical intervention, or hospitalization for the patient.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

• Brand Name: PADPRO P/C DC TRANSPARENT ZOLL, 12X7, 10/CS
• Type of Device: 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: 17304925
• MDR Text Key: 319186498
• Report Number: 1320894-2023-00134
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P200004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/03/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 2001Z
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/19/2023
• Initial Date FDA Received: 07/12/2023
• Supplement Dates Manufacturer Received: 07/12/2023
• Supplement Dates FDA Received: 08/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic