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

Model Number WMDARM

Device Problems Thermal Decomposition of Device (1071); Fire (1245); Material Split, Cut or Torn (4008)

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

Event Date 10/09/2021

Event Type  malfunction  

Manufacturer Narrative

Based on information provided, kci is reporting this event as a device malfunction that has the potential to result in injury if the malfunction were to recur.It was confirmed that no harm or injury occurred to the patient or others due to this event.An evaluation of the power cords is currently pending their return.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 (b)(6) 2021, the following information was provided to kci by the patient: the power supply box allegedly caught fire, sparked and smoked when plugging in to charge the activ.A.C.¿ ion progress¿ remote therapy monitoring system.There was no harm or injury to the patient or others.On (b)(6) 2021, the following information was provided to kci by the patient: the fire was at the black box along the cord.There was a puff of smoke followed by 5-7 sheets of sparks, each about 2-3 inches.The patient was nearby and managed to disconnect it immediately.The patient had to wiggle the power cord at times to get the charge light to change from yellow to green.The patient reported it melted the plastic and confirmed there was no damage or injury other than to the black box.No photos were available.An evaluation of the power cords is currently pending their return.

Manufacturer Narrative

Based on additional information regarding the power cord, it was determined that the power cord did not cause or contribute to death or serious injury and a malfunction likely to cause death or serious injury was not confirmed by kci quality engineering.Therefore, this event is not reportable.

Event Description

On (b)(6) 2022, a device evaluation of the power cords was completed by kci quality engineering.Visual inspection of the power cord confirmed the insulation was damaged at the strain relief, exposing the electrical conductors.The cause and timing of the damage is indeterminate.Results of visual inspection indicate the damage did not result in a sustainable fire where flames or smoke occurred.

• 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: 12755423
• MDR Text Key: 280259961
• Report Number: 3009897021-2021-00261
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WMDARM
• Device Catalogue Number: 420095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2021
• Date Manufacturer Received: 01/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2021
• 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 Age: 61 YR
• Patient Sex: Female