MAUDE Adverse Event Report: KINETIC CONCEPTS, INC. ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM; OMP

Model Number WNDARM

Device Problem Smoking (1585)

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

Event Date 11/03/2022

Event Type  malfunction  

Event Description

On (b)(6) 2022, the following information was reported to kci by the patient: the activ.A.C.¿ ion progress¿ remote therapy monitoring system power cord started smoking from the power brick when the cord was plugged into the wall outlet.On (b)(6) 2022, the following information was reported to kci by the patient: there were no fire or flames from the power cord, only a stream of smoke that ceased once the power cord was unplugged.There was no injury to the patient or bystanders.On (b)(6) 2022, the device and power cords were tested per quality control procedure by the kci service center, and passed the quality control checks and met specifications.On (b)(6) 2022, the device and power cords were placed with the patient.On (b)(6) 2022, the device was tested per quality control procedure by the kci service center, and the unit passed the quality control checks and met specifications.The affected power cords were not available to return to kci quality engineering for evaluation.

Manufacturer Narrative

After reviewing the information provided, kci is reporting this event as a device malfunction that has the potential to result in injury if the malfunction were to recur.There were no injuries to the patient or others due to the alleged event.The affected power cords were not available to return to kci quality engineering for evaluation.Device labeling, available in print and online, states: warnings: important information for users: in order for kci products to perform properly, kci recommends the following conditions: use this product only in accordance with this manual and applicable labeling.Ensure the electrical installation of the room complies with the appropriate national electrical wiring standards.Do not operate this product if it has damaged power cord, power supply or plug.If these components are worn or damaged, contact kci.Do not drop or insert any object into any of the opening or tubing of this product.Keep the unit away from heated surfaces.Do not modify the therapy unit or dressing.Do not connect this product or its components to devices not recommended by kci.Avoid spilling fluids on any part of this product.Fluids remaining on the electrical controls can cause corrosion that may cause the electronic components to fail.Component failures may cause the unit to operate erratically, possibly producing potential hazards to patient and staff.If spills do occur, unplug the unit immediately and clean with an absorbent cloth.Ensure there is no moisture in or near the power connection and power supply components before reconnecting power.If the product does not work properly, contact kci.Disclaimer: this information is submitted pursuant to 21 cfr 803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a kinetic concepts, inc.Product malfunctioned, is defective or has caused serious injury.

• Brand Name: ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM
• Type of Device: OMP
• Manufacturer (Section D): KINETIC CONCEPTS, INC.; san antonio TX 78249
• Manufacturer Contact: steven jackson ; 6203 farinon drive; san antonio, TX 78249 ; 2102556438
• MDR Report Key: 15886812
• MDR Text Key: 307572618
• Report Number: 3009897021-2022-00178
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 00849554005600
• UDI-Public: 0100849554005600
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201571
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WNDARM
• Device Catalogue Number: 420095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2022
• Date Manufacturer Received: 11/03/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/22/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Sex: Male