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

Model Number WNDARM

Device Problem Fire (1245)

Patient Problems Partial thickness (Second Degree) Burn (2694); Full thickness (Third Degree) Burn (2696)

Event Date 06/06/2022

Event Type  Injury  

Manufacturer Narrative

Based on the information provided, it cannot be determined that the alleged fire resulting in second and third degree burns to the patient is related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.Kci has made multiple unsuccessful attempts to obtain additional clinical information.A device evaluation is currently pending device return.Based on the additional information provided by the patient on (b)(6) 2022, this event is reportable.Device labeling, available in print and online, states: warnings: important information for users: in order for kci products to perform properly, kci recommends the following conditions.Use this product only in accordance with this manual and applicable labeling.Ensure the electrical installation of the room complies with the appropriate national electrical wiring standards.Do not operate this product if it has damaged power cord, power supply or plug.If these components are worn or damaged, contact kci.Do not drop or insert any object into any of the opening or tubing of this product.Keep the unit away from heated surfaces.Do not modify the therapy unit or dressing.Do not connect this product or its components to devices not recommended by kci.Avoid spilling fluids on any part of this 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) 2022, the following information was reported to kci by the nurse: the patient experienced a fire in personal residence and is currently in a higher level care inpatient facility.The patient is no longer on v.A.C.® therapy.The home device assigned to this patient was destroyed in the incident.On (b)(6) 2022, the following information was reported to kci by the patient: the activ.A.C.¿ ion progress¿ remote therapy monitoring system allegedly started a fire and burned the patient's new bed and bedroom.The device is burned up.The patient allegedly experienced burn wounds.On (b)(6) 2022, the following information was reported to kci by the patient: the activ.A.C.¿ ion progress¿ remote therapy monitoring system allegedly caught on fire in the patient's home and burned the home down.The patient is in the hospital with second and third-degree burns.Upon discharge, the patient will return the device.The local fire department is investigating the cause of the fire.No additional information provided.Per review of online public records: the alleged fire occurred on (b)(6) 2022.A device evaluation for the activ.A.C.¿ ion progress¿ remote therapy monitoring system is currently pending return of the device.

Manufacturer Narrative

Based on the additional information regarding the device, kci's assessment remains the same; it cannot be determined that the alleged fire resulting in second and third degree burns to the patient is related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.The device passed quality control checks before patient placement and based on the evidence provided and analysis of the returned products, the device and power cords were not the source of the alleged heat event.

Event Description

On (b)(6) 2022, a device evaluation was completed by kci quality engineering.On (b)(6)2022, the device was tested per quality control procedure by the kci service center, and the device passed and met specifications.On (b)(6) 2022, the device was placed with the patient.On (b)(6) 2022, the device was evaluated per quality control procedure by kci quality engineering.External inspection revealed the device had been exposed to a heat event.Damage to the exterior of the device was severe and resulted in the remote therapy monitoring module missing and therapy accessories melted to the exterior of the device.Internal inspection of the device revealed evidence of several melted plastic and rubber components; however, there was no evidence that smoke or fire emanated from within the device.Inspection of the ac power cord did not reveal evidence of thermal or physical damage to the wire insulation or connectors.Inspection of the dc power supply revealed evidence of thermal damage to the wire insulation and barrel connector.Based on the evidence provided and analysis of the returned products, the device and power cords were not the source of the alleged heat event.

• Brand Name: ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING 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: 15033650
• MDR Text Key: 296040911
• Report Number: 3009897021-2022-00124
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 00849554005600
• UDI-Public: 0100849554005600
• 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: Other,Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WNDARM
• Device Catalogue Number: 420095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 10/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2021
• 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 Outcome(s): Hospitalization; Life Threatening
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White