MAUDE Adverse Event Report: KCI USA,INC. V.A.C.® FREEDOM; OMP

Model Number WNDFRE

Device Problems Thermal Decomposition of Device (1071); Charred (1086)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/25/2015

Event Type  malfunction  

Manufacturer Narrative

Device labeling, available in print and online, states: liquids remaining on the electronic controls can cause corrosion that may cause the electronic components to fail.Component failures may cause the unit to operate erratically, possibly producing potential hazard to patient and staff.Possible risk of electric shock - v.A.C.® therapy unit must only be used with kci-supplied power supply that is suitable for your country's voltage.Connect power cord supply with dry hands to v.A.C.® therapy unit first before connecting to main voltage.Use device in dry locations only.Keep the v.A.C.Freedom® therapy system away from heated surfaces.Avoid spilling fluids on any part of the v.A.C.Freedom® therapy unit.Never operate this product if it has a damaged power cord, power supply or plug.If the power cord, power supply or plug is worn or damage contact kci.Do not remove the protective cover of the serial port, which is located on the back the of the v.A.C.Freedom® unit.This port is to be used only with devices specified by kci and which comply with applicable iec standards.Under no circumstances should a battery, charger, or mains adapter, other than those supplied with the v.A.C.Freedom®, be used with the v.A.C.Freedom® system.

Event Description

On sep 25 2015, the following information was reported to the kci representative by a nurse: a freedom unit placed on a patient had caught fire.There was no reported injury to the patient or others.On sep 28 2015, the following information was reported to kci by the nurse: there was a smoke smell detected upon entering the patient's room.A visual inspection of the unit found what appeared to be a melted area on the side of the unit where the canister was attached.The unit did not alarm, make any noise, or fluctuate in pressure prior to the event.There was no visible smoking, fire, or sparking and there was no damage to anything else in the room.There was no harm or injury to the patient who was placed on an alternate dressing until a new unit arrived.A review of service records identified the device with cords passed qc checks and met specifications before placement.On (b)(6) 2015, kci quality engineering conducted a physical examination of the device and power cord.No physical damaged was observed on the cords, power supply, or plugs.Inspection of the unit's canister housing (internal and external) revealed an area of damage and charred residue.Internal inspection of the unit revealed the source for the heat event to be an electrical short in the unit's battery charger assembly.The insulation of the battery charger assembly's wiring was found damaged, which exposed the assembly's electrical conductors.The black residue, along with exposed electrical conductors provide evidence of an electrical short with heat event.A root cause investigation is in process.

Manufacturer Narrative

Based on the information provided, kci has determined this event is not reportable.Device labeling, available in print and online, states: liquids remaining on the electronic controls can cause corrosion that may cause the electronic components to fail.Component failures may cause the unit to operate erratically, possibly producing potential hazard to patient and staff.Possible risk of electric shock - v.A.C.Therapy unit must only be used with kci-supplied power supply that is suitable for your country's voltage.Connect power cord supply with dry hands to v.A.C.Therapy unit first before connecting to main voltage.Use device in dry locations only.Keep the v.A.C.Freedom therapy system away from heated surfaces.Avoid spilling fluids on any part of the v.A.C.Freedom therapy unit.Never operate this product if it has a damaged power cord, power supply or plug.If the power cord, power supply or plug is worn or damage contact kci.Do not remove the protective cover of the serial port, which is located on the back the of the v.A.C.Freedom unit.This port is to be used only with devices specified by kci and which comply with applicable iec standards.Under no circumstances should a battery, charger, or mains adapter, other than those supplied with the v.A.C.Freedom, be used with the v.A.C.Freedom system.

Event Description

Kci has determined that, although a device malfunction was confirmed, the malfunction is not likely to cause or contribute to a death or serious injury if it were to recur.Kci has determined the likelihood of serious injury or death is remote and the malfunction did not impact the device in a catastrophic way.In addition, the customer stated the malfunction did not result in fire or visible smoke.

• Brand Name: V.A.C.® FREEDOM
• 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: 5173638
• MDR Text Key: 29217419
• Report Number: 3009897021-2015-00101
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062227
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: WNDFRE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2015
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2003
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1