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

Model Number WNDACT

Device Problems Thermal Decomposition of Device (1071); Fire (1245); Smoking (1585)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 03/08/2019

Event Type  malfunction  

Manufacturer Narrative

Based on the information provided, the cause and timing of the damage to the activ.A.C.¿ therapy unit and power cord is indeterminate.The device along with the power supply and power cords are being sent to an independent laboratory for further investigation.It was determined that the redness to the fingers did not to meet the definition of a serious injury as defined in qp-02-03 as aligned with 21 cfr 803.3, and the redness was considered to be a 1st degree burn.The kci representative experienced redness to the fingers that did not require medical or surgical intervention.Device labeling, available in print and online, states: a three-pronged electrical outlet is recommended for use with this product.If you do not have a three-pronged outlet, use a three-pronged adapter.For safe use of the adapter, secure the ground wire to the center screw of the outlet cover plate.Extension cords are not recommended for use with this product.Do not overload your electrical outlets.Keep electrical cords out of traffic areas.To avoid damage to the therapy unit, use only the power supply and cord that comes with the unit.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 or damaged, contact kci.Do not connect this product or its components to device not recommended by kci.Keep the therapy unit away from heated surfaces.Although this product conforms to the intent of standard iec 60601-1-2 in relation to electromagnetic compatibility, electrical equipment may produce interference.If interference is suspected, separate the equipment 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.

Event Description

On (b)(6) 2019, the following information was reported by the kci representative: the activ.A.C.¿ therapy system allegedly began to smoke and caught fire for a "quick second" while charging.The power port is allegedly burnt, and the power cord connector tip reportedly melted into the unit.The kci representative experienced redness to the finger and did not seek medical attention.On (b)(6) 2019, the following information was reported by the kci representative: a puff of smoke was observed from the activ.A.C.¿ therapy system.On (b)(6) 2019, the device was tested per quality control procedure by kci field service and the unit passed the quality control checks.On (b)(6) 2019, kci quality engineering determined that an internal inspection of the device revealed a burnt power port and charring on the circuit board surrounding the port, with the connector tip of the power supply melted and embedded inside.The melted power cord connector tip is noticeable from the exterior.External inspection of the power cord revealed that the connector tip is melted off.The device along with the power supply and power cords are being sent to an independent laboratory for further investigation.

Manufacturer Narrative

Based on the outcome of the investigation, the cause of the damage is indeterminate.The report identified thermal damage which was likely caused by a highly resistive connection between the dc connector of the power supply and the power port of the activ.A.C.¿ unit.A highly resistive connection can be caused by loose connections and/or contamination between the dc connector and the power port of the activ.A.C.¿ unit.In a highly resistive connection, the resistance leads to a build-up of high temperature conditions at the physical connection.

Event Description

This event occurred within the kci technical service center using a power supply that is routinely used repeatedly for charging units before they are released back to the kci rental fleet.The outside testing facility identified the cause of the damage as indeterminate.The extent of the damage to the activ.A.C.¿ board and the power supply precludes a definitive determination of the event.Their report indicates thermal damage which was likely caused by a highly resistive connection between the dc connector of the power supply and the power port of the activ.A.C.¿ unit.A highly resistive connection can be caused by loose connections and/or contamination between the dc connector and the power port of the activ.A.C.¿ unit.In a highly resistive connection, the resistance leads to a build-up of high temperature conditions at the physical connection.

• Brand Name: ACTIV.A.C.¿ THERAPY SYSTEM
• Type of Device: OMP
• Manufacturer (Section D): KINETIC CONCEPTS, INC.; san antonio TX
• Manufacturer Contact: steven jackson ; 6203 farinon drive; san antonio, TX 78249 ; 2102556438
• MDR Report Key: 8484595
• MDR Text Key: 140963856
• Report Number: 3009897021-2019-00046
• 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: K063692
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: WNDACT
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2013
• 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