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

Catalog Number 2001M

Device Problem Defibrillation/Stimulation Problem (1573)

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

Event Date 04/01/2024

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 sales representative reported on behalf of the customer, that the 2001m, padpro:ad;rtrans el, 12x7 was being used on approximately 01apr24 during a code blue when it was reported ¿they tried to shock a patient multiple times and were unsuccessful.We were also told the patient was over 500lbs, therefore had a lot of impedance.Lastly, as of recently stryker has been handing out letters to their customers stating that they can¿t use 3rd party pads on their defibrillators, which may or may not have influenced the situation.¿.It was also reported that an unknown alternate device was used.Further assessment was requested but no further information is available.There was no report of medical intervention, or extended hospitalization to the patient or user.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

The device will not be returned, and no photographic evidence was provided.Therefore, a device malfunction cannot be verified.A two-year lot history review cannot be conducted as a lot number was not provided.A device history record (dhr) review cannot be conducted as a lot number was not provided.(b)(4).Per the instructions for use, the user is advised to inspect multifunction electrode for damage, wear and loose connections prior to use.Discard if any damage or wear is found.Visually examine the pad before placement.Check that adhesive is intact and undamaged.Do not use any damaged pads, replace pads if necessary.After patient movement due to muscle contraction or patient repositioning, press pads to skin to ensure good coupling between pads and skin.Apply a new pair of electrodes if the electrodes do not adhere properly to the patient.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, that the 2001m, padpro:ad;rtrans el, 12x7 was being used on approximately 01apr24 during a code blue when it was reported ¿they tried to shock a patient multiple times and were unsuccessful.We were also told the patient was over 500lbs, therefore had a lot of impedance.Lastly, as of recently stryker has been handing out letters to their customers stating that they can¿t use 3rd party pads on their defibrillators, which may or may not have influenced the situation.¿.It was also reported that an unknown alternate device was used.Further assessment was requested but no further information is available.There was no report of medical intervention, or extended hospitalization to the patient or user.This report is being raised on the basis of malfunction with potential for injury upon reoccurrence.

• Brand Name: PADPRO:AD;RTRANS EL, 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: 19180051
• MDR Text Key: 341612167
• Report Number: 1320894-2024-00109
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/22/2024

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: 2001M
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/01/2024
• Initial Date FDA Received: 04/25/2024
• Supplement Dates Manufacturer Received: 05/13/2024
• Supplement Dates FDA Received: 05/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic