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)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/01/2021

Event Type  malfunction  

Manufacturer Narrative

The original power cords associated with this complaint were not returned to kci quality engineering, therefore a physical evaluation could not be performed.Based on information provided, images provided to kci displayed evidence of thermal damage to the activ.A.C.¿ power supply.The cause and timing of the damage is indeterminate.It was confirmed that no harm or injury occurred to the patient or others due to this event.Device labeling, available in print and online, states: warnings: important information for users: 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 devices not recommended by kci.Keep this product away from heated surfaces.Although this product conforms to the intent of standard iec 60601-1-2 in relation to the electromagnetic compatibility, electrical equipment may produce interference.If interference is suspected, separate the equipment and contact kci.

Event Description

On 01-sep-2021, the following information was provided to kci by the patient: the power cord allegedly caught fire while charging the activ.A.C.¿ ion progress¿ remote therapy monitoring system and appeared melted.The alleged fire reportedly burned a hole in the patient's carpet with no harm or injury to the patient or others.On 22-sep-2021, a device evaluation was completed by kci quality engineering.Review of images provided to kci on 15-sep-2021 by the patient revealed thermal damage sustained to the external housing of the power supply and to the patient's carpet.

Manufacturer Narrative

Mdr-3009897021-2021-00231 submitted on (b)(6) 2021 noted the following: b5 describe event or problem: on (b)(6) 2021, the following information was provided to kci by the patient: the power cord allegedly caught fire while charging the activ.A.C.¿ ion progress¿ remote therapy monitoring system and appeared melted.D1 brand name: activ.A.C.¿ ion progress¿ remote therapy monitoring system d4 model #: wmdarm.Corrections: b5 describe event or problem: on (b)(6) 2021, the following information was provided to kci by the patient: the power cord allegedly caught fire while charging the activ.A.C.¿ therapy system and appeared melted.D1 brand name: activ.A.C.¿ therapy system.D4 model #: wndact.

Event Description

On (b)(6) 2021, the following information was provided to kci by the patient: the power cord allegedly caught fire while charging the activ.A.C.¿ therapy system and appeared melted.The alleged fire reportedly burned a hole in the patient's carpet with no harm or injury 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 78249
• Manufacturer Contact: steven jackson ; 6203 farinon drive; san antonio, TX 78249 ; 2102556438
• MDR Report Key: 12548603
• MDR Text Key: 273848658
• Report Number: 3009897021-2021-00231
• 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: K201571
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/18/2022

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: Lay User/Patient
• Device Model Number: WNDACT
• Device Catalogue Number: 340020
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/01/2021
• Initial Date FDA Received: 09/29/2021
• Supplement Dates Manufacturer Received: 09/01/2021
• Supplement Dates FDA Received: 01/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2018
• 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
• Patient Age: 70 YR
• Patient Sex: Male