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

Model Number WNDACT

Device Problems Thermal Decomposition of Device (1071); Smoking (1585); Device Contamination with Chemical or Other Material (2944)

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

Event Date 09/30/2021

Event Type  malfunction  

Manufacturer Narrative

Based on 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.Additional investigation of the device and power cord are in process.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.

Event Description

On (b)(6) 2021, the following information was reported to kci by the nurse: the activ.A.C.¿ therapy system was allegedly smoking.There were no injuries to the patient or others.On (b)(6) 2021, the following information was reported to kci by the nurse: the unit and/or the power cord allegedly produced a stream of smoke; smoking ceased once the unit was unplugged.No fire, flames, or sparks were observed, however, the power cord tip that plugs into the unit was noted to have allegedly melted.There were no injuries to the patient or others.On (b)(6) 2021, the device was tested per quality control procedure by kci service center, and the unit passed the quality control checks and met specifications.On (b)(6) 2021, the device was placed with the patient.On (b)(6) 2021, kci quality engineering performed an evaluation of the device.Inspection of the device revealed evidence of melted plastic on the device power port.Additionally, the dc power cord connector that plugs into the device was melted and damaged.The cause and timing of the damage could not be determined.The device and power cord were sent to a third party investigator to conduct further analysis.

Event Description

On 06-jan-2022, a device evaluation was completed by kci quality engineering containing additional investigation of the device and power cords by a third party investigator.Throughout the analysis, no evidence of electrical overstress was observed.However, evidence of elemental contamination and corrosion were documented in residues found on the exterior housing and interior components.All of the noted elements are consistent with elements found in human contamination and some cleaning agents.These contaminants, being ionic in nature, can induce current leakage across opposing potentials, which may eventually lead to electrical and thermal overstress, neither of which were observed.The cause and timing of the elemental contamination and corrosion are indeterminate.

Manufacturer Narrative

Based on the additional information provided, kci's assessment remains the same.Kci is reporting this event as a device malfunction that has the potential to result in injury if the malfunction were to recur.The cause and timing of the damage, elemental contamination and corrosion are indeterminate.

Event Description

On 06-jan-2022, a device evaluation was completed by kci quality engineering containing additional investigation of the device by a third party investigator.Throughout the analysis, no evidence of electrical overstress was observed.However, evidence of elemental contamination and corrosion were documented in residues found on the exterior housing and interior components of the device.All of the noted elements are consistent with elements found in human contamination and some cleaning agents.These contaminants, being ionic in nature, can induce current leakage across opposing potentials, which may eventually lead to electrical and thermal overstress, neither of which were observed.The cause and timing of the elemental contamination and corrosion are indeterminate.On 02-mar-2022, additional information was received by kci quality engineering regarding the analysis of the power cords by a third party investigator.It was identified that the power cords sent to the third party investigator were not associated with the reported event.Additionally, the power cords associated with the reported event were inadvertently discarded; therefore, the power supply and power cord are unavailable for further testing by a third party investigator.

Manufacturer Narrative

Fu#1 submitted on 17-jan-2022 noted the following: section b5 describe event or problem: on 06-jan-2022, a device evaluation was completed by kci quality engineering containing additional investigation of the device and power cords by a third party investigator.Throughout the analysis, no evidence of electrical overstress was observed.However, evidence of elemental contamination and corrosion were documented in residues found on the exterior housing and interior components.All of the noted elements are consistent with elements found in human contamination and some cleaning agents.These contaminants, being ionic in nature, can induce current leakage across opposing potentials, which may eventually lead to electrical and thermal overstress, neither of which were observed.The cause and timing of the elemental contamination and corrosion are indeterminate.Correction: section b2 outcomes attributed to adverse event: on 06-jan-2022, a device evaluation was completed by kci quality engineering containing additional investigation of the device by a third party investigator.Throughout the analysis, no evidence of electrical overstress was observed.However, evidence of elemental contamination and corrosion were documented in residues found on the exterior housing and interior components of the device.All of the noted elements are consistent with elements found in human contamination and some cleaning agents.These contaminants, being ionic in nature, can induce current leakage across opposing potentials, which may eventually lead to electrical and thermal overstress, neither of which were observed.The cause and timing of the elemental contamination and corrosion are indeterminate.Based on the correction and additional information regarding the power cords, kci's assessment remains the same.Kci is reporting this event as a device malfunction that has the potential to result in injury if the malfunction were to recur.The cause and timing of the damage, elemental contamination and corrosion are indeterminate.

• Brand Name: ACTIV.A.C.¿ THERAPY 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: 12701175
• MDR Text Key: 278511358
• Report Number: 3009897021-2021-00255
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 00878237008188
• UDI-Public: 0100878237008188
• 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: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 03/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WNDACT
• Device Catalogue Number: 340020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/24/2008
• 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: 60 YR
• Patient Sex: Male