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

Model Number WNDULT

Device Problems Thermal Decomposition of Device (1071); Power Problem (3010); 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 "charger block" allegedly caught fire and ignited part of the patient's bed linens that were draped from the bed down to the floor.The smoke was promptly detected and the fire extinguished.The patient was unharmed and remained on therapy with same unit after replacement of damaged power cord.The power cord is in transit pending receipt for device evaluation.

Manufacturer Narrative

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 (b)(6) 2015, the following was reported to the kci representative by the customer: the actual bed linens did not ignite as originally reported on (b)(6) 2015, there was only a blackening or soot on the fabric that was directly in contact with the power supply.On (b)(6) 2015, kci quality engineering (qe) completed an inspection of the returned power cords that revealed the female plug of the ac power cord and receptacle of the dc power supply adapter were both burnt and melted.Visual examination confirmed the returned ac power cord is not a cord distributed by acelity for use with the v.A.C.Ulta power supply.

Manufacturer Narrative

Based on information provided, kci has determined this event did not cause or contribute to death or serious injury.The power cord provided by the customer for evaluation was not the stock cord provided by kci.Separate examination of the cord by the external laboratory showed that it was equivalent to a kci approved power cord; however, kci has deemed the event a use error as the v.A.C.Ulta user manual provides instruction: to only use the power cables provided with the v.A.C.Ulta therapy unit; to not operate this product if it has a damaged power cord, power supply or plug; and if these components are worn, damaged to contact kci.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 nov 20 2015, kci quality engineering (qe), determined that the inspection of the returned power cords revealed that the female plug of the ac power cord and receptacle of the dc power supply adapter were both damaged (burnt/melted), consistent with customer complaint.Visual examination of the ac power cord determined it is not a cord qualified and distributed by (b)(4) for use in conjunction with the v.A.C.Ulta power supply (dc) and therapy unit.The v.A.C.Ulta user manual provides instruction to only use the power cables provided with the v.A.C.Ulta therapy unit.Conditions and acceptability for use of a substitute ac power cord in conjunction with the v.A.C.Ulta therapy units is unknown.The power cord was submitted to an external laboratory for further analysis.When the power supply was opened, there was no evidence of fluid ingress.The case showed evidence of external physical damage by force.There was evidence of severe charring and melting of the board near the ac plug but no external damage to the ac plug itself.The power cord provided by the customer for evaluation was not the stock cord provided by kci.Separate examination of the cord by the external laboratory showed that it was equivalent to a kci approved power cord; however, kci has deemed the event a use error as the v.A.C.Ulta user manual provides instruction: to only use the power cables provided with the v.A.C.Ulta therapy unit; to not operate this product if it has a damaged power cord, power supply or plug; and if these components are worn, damaged to contact kci.Kci qe determined device malfunction was confirmed.

• 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: 5111975
• MDR Text Key: 27062766
• Report Number: 3009897021-2015-00098
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Health Professional
• Type of Report: Followup,Followup
• Report Date: 01/19/2016

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?: Yes
• 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; Not provided
• Supplement Dates FDA Received: 11/23/2015; 01/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/02/2013
• 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