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 01/20/2023

Event Type  Death  

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 2001m-c, padpro:ad;rtrans el/lw, 12x7 was being used during an emergency situation on (b)(6) 2023 when it was reported ¿defibrillator pad arched and caught fire during use on a patient who had coded.¿ further assessment questioning found that the ¿pads used in emergency situation.Skin dry and intact.Likely not shaved b/c of urgency to defibrillate.Patient was pronounced deceased following additional code blue situation.The area was reddened, and some hair burned from the axilla area.The patient died of critical illness not the alleged burn.¿ it was also reported that the degree of burn was not diagnosed, and nothing was used to treat the burn due to critical need for cpr.The current status of the patient is deceased.This report is being raised on the basis of injury due unknown degree of burn.Furthermore, the information indicated the patient is deceased but not as a result of the pad incident.

Event Description

The sales representative reported on behalf of the customer 2001m-c, padpro:ad; rtrans el/lw, 12x7 was being used during an emergency situation on (b)(6) 2023 when it was reported ¿defibrillator pad arched and caught fire during use on a patient who had coded.¿ further assessment questioning found that the ¿pads used in emergency situation.Skin dry and intact.Likely not shaved b/c of urgency to defibrillate.Patient was pronounced deceased following additional code blue situation.The area was reddened, and some hair burned from the axilla area.The patient died of critical illness not the alleged burn.¿ it was also reported that the degree of burn was not diagnosed, and nothing was used to treat the burn due to critical need for cpr.The current status of the patient is deceased.This report is being raised on the basis of injury due unknown degree of burn.Furthermore, the information indicated the patient is deceased but not as a result of the pad incident.

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 21 complaints, regarding 22 devices, for this device family and failure mode.During this same time frame (b)(4) have been manufactured and shipped worldwide.(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.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.).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.We will continue to monitor for trends through the complaint system to assure patient safety.

Event Description

The sales representative reported on behalf of the customer 2001m-c, padpro:ad;rtrans el/lw, 12x7 was being used during an emergency situation on (b)(6) 2023 when it was reported ¿defibrillator pad arched and caught fire during use on a patient who had coded.¿ further assessment questioning found that the ¿pads used in emergency situation.Skin dry and intact.Likely not shaved b/c of urgency to defibrillate.Patient was pronounced deceased following additional code blue situation.The area was reddened, and some hair burned from the axilla area.The patient died of critical illness not the alleged burn.¿ it was also reported that the degree of burn was not diagnosed, and nothing was used to treat the burn due to critical need for cpr.The current status of the patient is deceased.This report is being raised on the basis of injury due unknown degree of burn.Furthermore, the information indicated the patient is deceased but not as a result of the pad incident.

Manufacturer Narrative

Reported event of ¿defibrillator pad arched and caught fire¿ is confirmed.Received one 2001m-c in unoriginal package.Lot number was not verified.Performed a visual inspection, there was hair and debris on both ground pads.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.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.).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.We will continue to monitor for trends 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: samantha dewberry ; 525 french road; utica, NY 13502 ; 3152230184
• MDR Report Key: 16395578
• MDR Text Key: 309743224
• Report Number: 1320894-2023-00040
• 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,Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date: 03/31/2023

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other
• Patient Ethnicity: Non Hispanic