MAUDE Adverse Event Report: KCI USA, INC. V.A.C.ULTA¿ THERAPY (SYSTEM, UNIT); OMP

Model Number WNDULT

Device Problems Thermal Decomposition of Device (1071); Smoking (1585)

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

Event Date 07/16/2017

Event Type  malfunction  

Manufacturer Narrative

The cause and timing of the damage is indeterminate.It was confirmed that no injury occurred to the patient or bystanders.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 v.A.C.Ulta¿ therapy (system, unit) or decreased electromagnetic immunity of the v.A.C.Ulta¿ therapy (system, unit).

Event Description

On (b)(6) 2017, the following information was provided to kci by the nurse: the patient's power cord was allegedly smoking with no injuries to the patient or bystanders noted.The nurse stated a different v.A.C.Ulta unit will be placed on the patient.On (b)(6) 2017, the device was tested per quality control (qc) procedure by kci field service, and the unit passed the qc checks and met specifications.On (b)(6) 2017, the device was placed with the patient.On (b)(6) 2017, kci quality engineering determined external inspection of the dc power supply adapter revealed evidence of physical damage and melted plastic on the plastic housing around the metal connector prongs.There was also evidence of fluid ingress staining and a foreign substance on the prongs.The cause of the physical damage inside the connector of the dc brick is indeterminate.No damage was found on the ac power cord.Internal inspection of the dc brick revealed evidence of a heat event due to smoke residue and black charring near the metal connector prongs, consistent with customer allegation of smoke.

• Brand Name: V.A.C.ULTA¿ THERAPY (SYSTEM, UNIT)
• Type of Device: OMP
• Manufacturer (Section D): KCI USA, INC.; san antonio TX
• Manufacturer Contact: steve jackson ; 6203 farinon drive; san antonio, TX 78249 ; 2102556438
• MDR Report Key: 6844254
• MDR Text Key: 84937033
• Report Number: 3009897021-2017-00097
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 00849554001244
• UDI-Public: 0100849554001244
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100657
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 09/06/2017

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: WNDULT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/08/2017
• Initial Date FDA Received: 09/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2015
• 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