MAUDE Adverse Event Report: KCI USA, INC. V.A.C.ULTA¿ THERAPY SYSTEM; OMP

Model Number WNDULT

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Electric Shock (2554); Partial thickness (Second Degree) Burn (2694); Full thickness (Third Degree) Burn (2696)

Event Date 08/18/2017

Event Type  Injury  

Manufacturer Narrative

Based on the device evaluation and the information provided, kci has confirmed the customer complaint.This event is being reported due to use error as the customer confirmed that the cna dropped the power cord exposing the wires at the brick connection and attempted to repair the damage, which inadvertently caused her to receive the shock.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.Use only the power supply provided with the therapy unit.Using any other power supply may damage the therapy unit.If environmental conditions (specifically, low humidity) pose a risk of static electricity, take care when handing the therapy unit while it is plugged into an ac wall outlet.In rare instances, discharge of static electricity when in contact with the therapy unit may cause the touch screen to darken, or the therapy unit to reset or turn off.If therapy does not restart by powering the unit off and then on, immediately contact kci.To isolate the therapy unit from the supply mains, unplug the ac power cord from the wall outlet.The use of electrical cables and accessories other than those specified in the manual or referenced documents may result in increased electromagnetic emissions from the v.A.C.Ulta¿ therapy (system, unit) or decreased electromagnetic immunity of the v.A.C.Ulta¿ therapy (system, unit).

Event Description

On (b)(6) 2017, the following information was reported to kci by the kci representative: the customer reported that a nurse was allegedly "shocked" by the unit during the patient's use of the v.A.C.Ulta¿ therapy system and was sent to the emergency room (er) at their facility.On (b)(6) 2017, the following information was reported to kci from kci representatives: the customer reported that it was a certified nursing assistant (cna) who allegedly received the "shock." the customer confirmed that the cna was not "shocked" by the unit, but the power cord.The cna dropped the power cord and cracked the brick connection when moving the unit.The cna tried to fix the problem and still use the power cord, but while touching the brick connection with the cords exposed wires she received a "shock" that per the cna, "traveled from her hand, up her arm, through her chest and into the other arm and out the other hand." the cna had picked the power cord up when it was still plugged in and in doing so the "shock" she received left marks on her skin.The cna went to the er and was placed on a heart monitor and was watched for further complications for approximately 5 hours.On (b)(6) 2017, the following information was reported to kci by the kci representative: the facility staff reported that when the cna allegedly received the "shock" she could not let go of the power cord and that someone had to knock it out of her hand to get her to release it.The facility staff also found upon a visible inspection of the damaged brick connection that there was what appeared to be a finger imprint on the brick connection after the event occurred.On sep 12 2017, the following information was reported to kci by the hospital representative: a cna received entrance and exit wounds on opposing thumbs of each hand and electrical burns to the palm of the right hand when touching a damaged power cord.The event had no impact on the patient.The cna was the only individual who suffered any harm or injury.No further information was provided.On (b)(6) 2017, the device was tested per quality control (qc) procedure by kci field service, and the unit with power cord passed the qc checks and met specifications.On (b)(6) 2017, the device was placed with the patient.On (b)(6) 2017, kci quality engineering (qe) determined that an external visual inspection of the dc brick revealed evidence of physical damage at the corners, resulting in splitting of the dc brick and exposing the internal electrical components.A thumbprint on the interior metal ground plate of the dc brick was also found.A verbal communication from the customer confirmed that they were aware that the power cord brick had physically split open and that the electrical components were exposed when the individual involved in the event attempted to pick it up near the metal connector prongs.The power cord damage was determined to be consistent with customer allegation of receiving a "shock.".

Manufacturer Narrative

(b)(4).

• Brand Name: V.A.C.ULTA¿ THERAPY SYSTEM
• Type of Device: OMP
• Manufacturer (Section D): KCI USA, INC.; san antonio TX
• Manufacturer Contact: steve jackson ; 6203 farinon drive; san antonio, TX 78249 ; 2102556438
• MDR Report Key: 6868948
• MDR Text Key: 86314470
• Report Number: 3009897021-2017-00096
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100657
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: WNDULT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other