MAUDE Adverse Event Report: KINETIC CONCEPTS, INC. V.A.C.ULTA¿ NEGATIVE PRESSURE WOUND THERAPY SYSTEM; OMP

Model Number WNDUCO

Device Problem Fire (1245)

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

Event Date 05/23/2019

Event Type  malfunction  

Manufacturer Narrative

Based on the information provided, an investigation in currently in process.It was confirmed that there were no reports of harm or injury to the patient or healthcare professionals.No additional information is available.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) 2019, the following information was reported to kci by the biomedical engineer: a fire allegedly occurred at the hospital's trauma ward, and a customer owned v.A.C.Ulta¿ negative pressure wound therapy system was in use at the time of the incident.It was confirmed that there were no reports of harm or injury to the patient or healthcare professionals.An investigation is underway to establish cause of the fire.On 28-may-2019, the following information was reported to kci by the biomedical engineer: the v.A.C.Ulta¿ negative pressure wound therapy system will not be available until the conclusion of the investigation by the customer.On 03-jun-2019, declaration no.(b)(4) was received by kci (b)(4) from (b)(6).It noted, on (b)(6) 2019 a fire started in a room where the patient was connected to a negative pressure wound therapy device.There is no information about the cause of the start of the fire.The v.A.C.Ulta¿ negative pressure wound therapy system was placed in quarantine.

Manufacturer Narrative

Mdr-3009897021-2019-00073_108387-iss sent on 21-jun-2019, section b5 stated: on 28-may-2019, the following information was reported to kci by the biomedical engineer: the v.A.C.Ulta¿ negative pressure wound therapy system will not be available until the conclusion of the investigation by the customer.Correction: on 27-may-2019, the following information was reported to kci by the biomedical engineer: the v.A.C.Ulta¿ negative pressure wound therapy system will not be available until the conclusion of the investigation by the customer.Additional information: initial reporter was updated from ni to (b)(6).Based on the information, kci is unable to determine if the alleged fire is related to v.A.C.Ulta¿ therapy system.Kci has made multiple unsuccessful attempts to obtain additional information and access to the device.A final report regarding this event is not available as the v.A.C.Ulta¿ therapy unit has not been provided to kci for investigation, due diligence by kci has not resulted in additional information or access to the device for evaluation.No evidence has been provided to kci that the fire was associated with the v.A.C.Ulta¿ therapy system.

Event Description

On 27-may-2019, the following information was reported to kci by the biomedical engineer: the v.A.C.Ulta¿ negative pressure wound therapy system will not be available until the conclusion of the investigation by the customer.The v.A.C.Ulta¿ unit was sold to the facility 30-jun-2014.The device is not covered under a warranty or service contract.As the device is customer owned, the last quality control check performed by kci was on 06-nov-2018.The device was tested per quality control procedure by kci and the unit passed the quality control checks.

• Brand Name: V.A.C.ULTA¿ NEGATIVE PRESSURE WOUND THERAPY SYSTEM
• Type of Device: OMP
• Manufacturer (Section D): KINETIC CONCEPTS, INC.; san antonio TX
• MDR Report Key: 8721654
• MDR Text Key: 148748290
• Report Number: 3009897021-2019-00073
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• PMA/PMN Number: K100657
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WNDUCO
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1