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

Model Number WNDACT

Device Problems Overheating of Device (1437); Sparking (2595); Environmental Particulates (2930)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/12/2018

Event Type  malfunction  

Manufacturer Narrative

Based on information provided, it cannot be determined if the alleged event is related to activ.A.C.¿ therapy system.It was confirmed that no harm or injury occurred to the patient or others.Device labeling, available in print and online, states: ensure the electrical installation of the room complies with the appropriate national electrical wiring standards.To avoid the risk of electrical shock, this product must be connected to a grounded power receptacle.Do not operate this product if it has a damaged power cord, power supply or plug.If these components are worn, damaged, contact kci.Do not connect this product or its components to device not recommended by kci.Keep this product away from heated surfaces.Although this product conforms to the intent of the directive 2004/108/ec in relation to the electromagnetic compatibility, all electrical equipment may produce interference.If interference is suspected, move equipment away for sensitive devices and contact kci.Avoid spilling fluids on any part of the 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.Do not use this product while bathing/showering or where it can fall or be pulled into a tub, shower or sink.Do not reach for product that has fallen into water.Unplug the unit immediately if plugged into electrical source.Disconnect the unit from dressing and contact kci.Use only the power supply provided with the therapy unit.Using any other power supply may damage the therapy unit.If environmental conditions (specifically, low humidity) pose a risk of static electricity, take care when handing the therapy unit while it is plugged into an ac wall outlet.In rare instances, discharge of static electricity when in contact with the therapy unit may cause the touch screen to darken, or the therapy unit to reset or turn off.If therapy does not restart by powering the unit off and then on, immediately contact kci.To isolate the therapy unit from the supply mains, unplug the ac power cord from the wall outlet.Power cord may present a tripping hazard.Ensure all cords are out of the areas where people may walk.The use of electrical cables and accessories other than those specified in the manual or referenced documents may result in increased electromagnetic emissions from the activ.A.C.¿ therapy system or decreased electromagnetic immunity of the activ.A.C.¿ therapy system.

Event Description

On (b)(6) 2018, the following information was reported to kci by the patient's family member: the power cord allegedly stated to smoke, spark, and became hot.No injuries were reported.On apr 13 2018, the following information was reported to kci by the patient's family member: it was alleged the power cord exhibited a burning smell and a few visible sparks but there was no visible smoke nor fire observed.The power cord's black brick was warm to the touch and left a blackened area on the floor.The patient's family member confirmed that no injuries were received to self, the patient, or others from the event.On apr 24 2018, the patient's family member provided images to kci.Assessment by quality engineering determined the images exhibited an appearance of soot or a black residue outline where the power cord brick had been placed.As of may 10 2018, the power cord has not been returned to kci for evaluation.

Event Description

On (b)(4) 2018, the device was tested per quality control procedure by kci field service, and the unit passed the quality control checks and met specifications.On (b)(6) 2018, the device was placed with the patient.On 14-may 2018, the power cord was tested per quality control procedure by kci by kci quality engineering and an external inspection of the returned power cord did not reveal any evidence of damage however the power cord did not function properly when plugged into a known good activ.A.C.¿ therapy system.Internal inspection of the dc brick revealed evidence of a heat event due to charring and black residue as well as corrosion due to fluid ingress.

Manufacturer Narrative

The cause and timing of the damage is indeterminate.It was confirmed that no injury occurred to the patient or others.

• Brand Name: ACTIV.A.C. THERAPY SYSTEM
• Type of Device: OMP
• Manufacturer (Section D): KINETIC CONCEPTS, INC.; san antonio TX
• MDR Report Key: 7509150
• MDR Text Key: 108497937
• Report Number: 3009897021-2018-00048
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 00878237008188
• UDI-Public: 0100878237008188
• Combination Product (y/n): N
• PMA/PMN Number: K063692
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 01/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WNDACT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2018
• Date Manufacturer Received: 05/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR