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

Catalog Number 2001M-C

Device Problem Fire (1245)

Patient Problem Burn(s) (1757)

Event Date 01/25/2023

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 customer reported that the device, 2001m-c, padpro: ad; rtrans el/lw, 12x7, was being used during an unknown procedure on (b)(6) 2023 when it was reported ¿when placed on patient defib pad arched and caught on fire burning patient.¿ further assessment answers were requested of the reporter and a good faith effort was completed; however, the reporter has not responded to our attempts for information.There was no report of medical intervention or hospitalization to patient or user.This report is being raised on the basis of injury due to unknown degree of burn.

Manufacturer Narrative

The device has not been returned to date and no photographic evidence has been provided; therefore, the reported even cannot be verified.A device history review cannot be conducted as a lot number was not provided.A two-year lot history review cannot be conducted as a lot number was not provided.A two-year review of complaint history revealed there has been a total of (b)(4) complaints, regarding (b)(4) devices, for this device family and failure mode.During this same time frame (b)(4) 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 (b)(4).Per the instructions for use, the user is advised the following: inspect multi-function electrode for damage, wear and loose connections prior to use.Always apply electrodes to flat areas of skin.If possible, avoid folds if skin such as those underneath the breast or those visible on obese individuals.Inadequate pad adhesion can lead to arcing or skin burns.Discard if any damage or wear is found.Do not apply multi-function electrodes over broken skin.Do not apply any substance to the skin surface that will leave a residue (e.G.Lotions, oils, etc.).We will continue to monitor for trends through the complaint system to assure patient safety.

Event Description

The customer reported that the device, 2001m-c, padpro:ad;rtrans el/lw, 12x7, was being used during an unknown procedure on (b)(6) 2023 when it was reported ¿when placed on patient defib pad arched and caught on fire burning patient.¿ further assessment answers were requested of the reporter and a good faith effort was completed; however, the reporter has not responded to our attempts for information.There was no report of medical intervention or hospitalization to patient or user.This report is being raised on the basis of injury due to unknown degree of burn.

• 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: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 16399006
• MDR Text Key: 309777385
• Report Number: 1320894-2023-00042
• 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: Health Professional,User Facility,Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 03/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2023
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Ethnicity: Non Hispanic