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

Model Number WNDSHM

Device Problem Temperature Problem (3022)

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

Event Date 05/17/2021

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 is in process.Device labeling, available in print and online, states: warnings: important information for users.The v.A.C.Simplicity¿ therapy unit is a medical device, not a toy.Keep away from children, pets and pests as they can damage the dressing and therapy unit and affect performance.Keep the therapy unit free from dust and int as they can also damage the dressing and therapy unit and affect performance.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 17-may-2021, the following information was provided to kci by the patient: the v.A.C.Simplicity¿ therapy system allegedly "burned up." the v.A.C.Simplicity¿ therapy system was reportedly alarming, type unknown, and the patient allegedly observed smoking with no sparking or injuries.The "first part" of the power cord that connects from the wall to the brick was disposed of because it was reportedly "smoking and hot as could be".The part of the power cord that connects the brick to the unit was not smoking but was burned up about 4 inches off the brick.The patient also stated the "carrying case was burned up".The patient confirmed the power cord was not plugged into the wall.On (b)(6) 2021, the following information was provided to kci by the patient: the patient stated a month ago the v.A.C.Simplicity¿ therapy system caught fire due to an electrical fire to power cord.Patient confirmed the v.A.C.Simplicity¿ therapy system was plugged into the wall.A device evaluation of the v.A.C.Simplicity¿ therapy system is pending completion.

Manufacturer Narrative

H4 device manufacture date: the specific manufacture day is unknown, thus 01-jun-2016 was utilized.Based on additional information provided regarding the device, 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.Kci confirmed the power supply and cord were discarded; therefore, it cannot be determined whether the power supply or power cord caused or contributed to the thermal damage on the exterior of the device.

Event Description

Kci confirmed the power supply and cord were discarded; therefore, it cannot be determined whether the power supply or power cord caused or contributed to the thermal damage on the exterior of the device.

• Brand Name: V.A.C. SIMPLICITY THERAPY SYSTEM
• Type of Device: OMP
• Manufacturer (Section D): KINETIC CONCEPTS, INC.; san antonio TX 78249
• MDR Report Key: 12425018
• MDR Text Key: 274543510
• Report Number: 3009897021-2021-00212
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• PMA/PMN Number: K201571
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 10/08/2021

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 Model Number: WNDSHM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2021
• Initial Date Manufacturer Received: 05/17/2021
• Initial Date FDA Received: 09/03/2021
• Supplement Dates Manufacturer Received: 09/14/2021
• Supplement Dates FDA Received: 10/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1