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

Model Number WNDULT

Device Problems Thermal Decomposition of Device (1071); Insufficient Information (3190)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/31/2015

Event Type  malfunction  

Manufacturer Narrative

Kci's quality control cleaning process performed prior to each patient placement includes inspection and replacement if the power cord is damaged.

Event Description

On (b)(6) 2015, the following was reported to the kci representative by the customer: the v.A.C.Utla power cord had allegedly caught fire.On (b)(6) 2015, the following was reported to the kci representative by the customer: there were no injuries to the patient nor any bystanders.The nurse was in the room, saw the flame and extinguished the fire.The damage was at the "junction box" between the two chords.The power cord has been submitted to an outside company for root cause analysis.

Manufacturer Narrative

Based on information provided, kci has determined this event did not cause or contribute to death or serious injury.Although the exact cause of the power supply to malfunction has not been identified to date, the malfunction of the power supply may have affected the device in a catastrophic way (evidence of fire) that may lead to a death or serious injury if it were to recur.Therefore, kci has determined that is event is reportable.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.-keep this product away from heated surfaces.-although this product conforms to the intent of the standard iec 60601-1-2 in relation to the electromagnetic compatibility, electrical equipment my produce interference.If interference is suspected, separate the equipment and contact kci.-avoid spilling fluids on any part of the 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.-do not use this product while bathing/showering or where it can fall or be pulled into a tub, shower or sink.-do not reach for product that has fallen into water.Unplug the unit immediately if plugged into electrical source.Disconnect the unit from dressing and contact 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.-power cord may present a tripping hazard.Ensure all cords are out of the areas where people may walk.-the use of electrical cables and accessories other than those specified may result in increase electromagnetic emissions from the unit or decreased electromagnetic immunity of the therapy unit.

Event Description

On aug 26 2015, the device was tested per quality control (qc) procedures by kci field service, and the unit passed the qc checks and met specifications.On sep 17 2015, the device was tested per quality control (qc) procedures by kci quality engineering (qe), and the unit passed the qc checks and met specifications.The evaluation of the returned dc power supply adapter revealed damage consistent with the customer complaint.External inspection of the dc power supply adapter found a fractured area on the side of the power module which exposed the adapter's internal components.Internal inspection of the power supply revealed evidence of rust, corrosion and a heat event.Results of evaluation indicate the most likely cause for the heat related damage to be some type of conductive liquid entering into the power module in the end user's application, causing the circuit to short out.While exact cause and timing for the damage to the dc power supply is indeterminate, kci field services did confirm that the casing of the dc power supply adapter was already found fractured at time of retrieval from customer.There was no fault found with the returned ac power cord.The customer complaint was confirmed in kci qe.

• Brand Name: V.A.C.ULTA THERAPY
• Type of Device: OMP
• Manufacturer (Section D): KCI USA,INC.; san antonio TX
• Manufacturer Contact: paul arrendell ; 6203 farinon drive; san antonio, TX 78249 ; 2105154108
• MDR Report Key: 5112002
• MDR Text Key: 27062458
• Report Number: 3009897021-2015-00099
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Followup
• Report Date: 01/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WNDULT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/29/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2012
• 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