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

Model Number WNDSHM

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

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

Event Date 10/23/2020

Event Type  malfunction  

Manufacturer Narrative

Device and power cords not returned.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.No evidence has been provided to kci that the smoke damage to the patient's ceiling was associated with the v.A.C.Simplicity¿ therapy system power supply.Multiple unsuccessful attempts have been made to retrieve the device and power cords; therefore, a device evaluation could not be performed.

Event Description

On 23-oct-2020, the following information was provided to kci by the patient: the v.A.C.Simplicity¿ therapy system power supply allegedly smoked and melted causing smoke damage to the patient's ceiling.The fire department was called and the patient was out of the home for smoke damage.No injuries were sustained.On 31-aug-2021, the following information was provided to kci by the patient: the patient stated there were no photos of the reported damage.No additional information available.On 11-aug-2020, the device and power cords were tested per quality control procedure by kci service center, and passed the quality control checks and met specifications.On (b)(6) 2020, the device was placed with the patient.Multiple unsuccessful attempts have been made to retrieve the device and power cords; therefore, a device evaluation could not be performed.

• Brand Name: V.A.C. SIMPLICITY 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: 12422976
• MDR Text Key: 269855648
• Report Number: 3009897021-2021-00215
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 00849554006515
• UDI-Public: 0100849554006515
• 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
• Report Date: 09/03/2021

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: Health Professional
• Device Model Number: WNDSHM
• Device Catalogue Number: 414062
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/23/2020
• Initial Date FDA Received: 09/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2014
• 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