MAUDE Adverse Event Report: KATECHO, INC. PADPRO:AD;RTRANS EL/LW, 12X7; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Catalog Number 2001M-C

Device Problem Insufficient Information (3190)

Patient Problems Burn(s) (1757); Skin Discoloration (2074)

Event Date 09/20/2022

Event Type  Injury  

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.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The sales representative reported on behalf of the customer that the device, 2001m-c, padpro:ad;rtrans el/lw, 12x7 was being used on (b)(6) 2022 during a defibrillation procedure and the ¿3 different patients received what appeared to be mild burns where the defib pads were placed during the procedures.No overlying body hair was present during defibrillation.¿.The procedure was completed with medtronic/stryker physio pads.There was no delay to the procedure.After further assessment it was discovered that ¿the site where the pad was applied was shaved and dry when the pad was applied.The pad was fully adhered to the patient and there were no air pockets or "tenting" of the applied pad.¿ the degree of burn is not known.There was no medical/surgical intervention reported.This report is being raised on the basis of injury due to unknown degree of burn to patient.

Event Description

The sales representative reported on behalf of the customer that the device, 2001m-c, padpro:ad;rtrans el/lw, 12x7 was being used on 20sep22 during a defibrillation procedure and the ¿3 different patients received what appeared to be mild burns where the defib pads were placed during the procedures.No overlying body hair was present during defibrillation.¿.The procedure was completed with medtronic/stryker physio pads.There was no delay to the procedure.After further assessment it was discovered that ¿the site where the pad was applied was shaved and dry when the pad was applied.The pad was fully adhered to the patient and there were no air pockets or "tenting" of the applied pad.¿ the degree of burn is not known.There was no medical/surgical intervention reported.This report is being raised on the basis of injury due to unknown degree of burn to patient.

Manufacturer Narrative

Additional 510k: p200004 manufacturer narrative: reported event is confirmed based on photographic evidence.A two-year lot history review was conducted and found a total of 3 events involving a total of 3 devices for this lot number.A device history record was requested and to date, a response was not received; therefore, a review cannot be conducted.A two-year review of complaint history revealed there has been a total of 15 reports, regarding 16 devices, for this device family and failure mode.During this same time frame 2,689,930 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 0.000006.Per the instructions for use, the user is advised the following: inspect multi-function electrode for damage, wear and loose connections prior to use.Discard if any damage or wear is found.Do not apply multifunction electrodes over broken skin.Do not apply any substance to the skin surface that will leave a residue (e.G.Lotions, oils, etc.).This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: PADPRO:AD;RTRANS EL/LW, 12X7
• 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: robin drum ; 11311 concept blvd; largo, FL 33773 ; 8653881978
• MDR Report Key: 15563649
• MDR Text Key: 301369544
• Report Number: 1320894-2022-00205
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K014209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 10/31/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: 2001M-C
• Device Lot Number: Y08112207
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/22/2022
• Initial Date FDA Received: 10/07/2022
• Supplement Dates Manufacturer Received: 10/20/2022
• Supplement Dates FDA Received: 10/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MEDTRONIC/STRYKER PHYSIO PADS.; MEDTRONIC/STRYKER PHYSIO PADS.
• Patient Outcome(s): Other
• Patient Ethnicity: Non Hispanic