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); Overheating of Device (1437); Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/29/2019

Event Type  malfunction  

Manufacturer Narrative

Based on information provided, the cause and timing of the damage to the activ.A.C.¿ power cord is indeterminate.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.

Event Description

On (b)(6) 2019, the following information was reported to kci by the case manager: the patient was lying in bed with the power cord on the floor, and reportedly smelled burning plastic.The activ.A.C.¿ therapy system allegedly "blew up" overnight, and the fire alarm was activated.The patient disconnected the power cord from the wall and was able to reset power.There were reportedly two joining pieces of plastic tubing that allegedly "caught alight." the family member confirmed the patient did not receive any burns and did not get hurt.On 06/21/2019, the device was tested per quality control procedure by kci service center, and the unit passed the quality control checks and met specifications.On (b)(6)2019, the device was placed with the patient.On 08/07/2019, kci quality engineering reviewed images which exhibited thermal damage at the connection between the ac power cord and the dc brick.Thermal damage on the dc brick was observed.The cause of the damage is indeterminate.

Event Description

On 03-sep-2019, kci quality engineering received the power cords for evaluation.On 11-sep-2019, kci quality engineering noted thermal damage at the connection between the dc power supply and ac power cord.The cause and timing of the heat event is indeterminate; therefore, kci is sending the power cord to an outside testing facility for further evaluation.

Manufacturer Narrative

Based on the information pending regarding the device, kci's assessment remains the same; the cause of the damage is indeterminate.There is no injury associated with this event.Kci is reporting this event as a device malfunction that has the potential to result in injury if it were to recur.

Event Description

On 31-oct-2019, kci quality engineering reviewed the results of the investigation completed by the independent laboratory.The short circuit event and localized heating between the line and neutral contacts would have resulted in the thermal damaged observed at the ac connection port.The cause of the short circuit event is indeterminate.

Manufacturer Narrative

Based on the review of the independent laboratory investigation, kci's assessment remains the same; the cause of the damage is indeterminate.There is no injury associated with this event.

• Brand Name: ACTIV.A.C.¿ THERAPY SYSTEM
• Type of Device: OMP
• Manufacturer (Section D): KINETIC CONCEPTS, INC.; san antonio TX
• MDR Report Key: 8937976
• MDR Text Key: 155775568
• Report Number: 3009897021-2019-00168
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• PMA/PMN Number: K063692
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: WNDACT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2019
• Date Manufacturer Received: 10/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1