MAUDE Adverse Event Report: KINETIC CONCEPTS, INC. V.A.C. FREEDOM¿ THERAPY (SYSTEM); OMP

Model Number WNDFRE

Device Problems Thermal Decomposition of Device (1071); Smoking (1585); Sparking (2595)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/16/2017

Event Type  malfunction  

Manufacturer Narrative

The cause and timing of the damage is indeterminate.It was confirmed that no injury occurred to the patient or bystanders.Device labeling, available in print and online, states: -specifications: iec classification - ipx0 -ensure the electrical installation of the room complies with the appropriate national electrical wiring standards.-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 damaged, contact kci -do not use attachments not recommended by kci.-keep the v.A.C.Freedom¿ therapy (system) away from heated surfaces.-although the v.A.C.Freedom¿ therapy (system) conforms to standard iec 60601-1-2 in relation to electromagnetic compatibility, electrical equipment may product interference.If interference is suspected, separate the equipment and contact kci.-warning: 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 hazards to patient and staff.-avoid spilling fluids on any part of the v.A.C.Freedom¿ therapy (system).-if spills do occur, unplug the unit immediately if plugged into electrical source and clean the unit with an absorbent cloth.Ensure there is no moisture in or near the power connection and power supply components before reconnecting power.If the v.A.C.Freedom¿ therapy (system) is not working properly, contact kci.-do not use v.A.C.Freedom¿ therapy (system) while bathing/showering or where it can fall or be pulled into a tub, shower or sink.-caution: use only the power supply provided with the v.A.C.Freedom¿ therapy (system).Using any other power supply may damage the v.A.C.Freedom¿ therapy (system).-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.-caution: power cords may present a tripping hazard.Ensure that all cords are out of the areas where people may walk.-caution: avoid spilling fluids on any part of the therapy unit.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 hazards to patient or caregiver.Particular care must be taken when handling undiluted disinfectant concentrate or chlorine bleach, including proper shielding of eyes.Electrical warnings: -warning: do not remove the protective cover of the serial port, which is located on the back of the v.A.C.Freedom¿ therapy (system).This port is to be used with device specified by kci and which comply with applicable iec standards.-warning: under no circumstances should a battery, charger, or main adaptor, or other than those supplied with the v.A.C.Freedom¿ therapy (system) but used with the v.A.C.Freedom¿ therapy (system).Note: failure to use kci-specified power supply will void electrical safety agency approval and may lead to electrical shock hazard.

Event Description

On (b)(6) 2017, the following information was provided to kci by the central supply representative: the v.A.C.Freedom¿ therapy (system) was allegedly sparking and smoking with no injuries to the patient or staff.On (b)(6) 2017, the device was tested per quality control (qc) procedure by kci field service, and the unit 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 determined the device revealed evidence of thermal damage to the data port assembly via external inspection.Further evaluation found evidence of a foreign substance could be seen on the device housing, in the data port assembly, and within the data port protective cover.Internal inspection of the device revealed the foreign substance within the device as well.There was also thermal damage to the insulation of the data port wires, which exposed the electrical conductors.The composition and source of the foreign substance could not be determined; however it is consistent with fluid ingress.The device was reassembled and plugged into the original power cords.The device immediately produced a burnt odor and smoke began to emit from the data port connection.The device would not power up on battery power or when plugged in.Functional testing could not be performed.The returned power cords were found to be in good condition and to function properly.

Manufacturer Narrative

Correction: describe event or problem originally stated, on aug 01 2017, the device was tested per quality control (qc) procedure by kci field service, and the unit passed.Correction: on aug 01 2017, the device was tested per quality control (qc) procedure by field service, and the unit passed.This event is reported as potential use error due to fluid ingress.

Event Description

On aug 01 2017, the device was tested per quality control (qc) procedure by field service, and the unit passed the qc checks and met specifications.On (b)(6) 2017, the device was placed with the patient.On nov 03 2017, kci quality engineering determined visual inspection of the device in kci quality engineering revealed evidence of thermal damage to the data port connection as well as the data port wire insulation, which exposed the electrical conductors.A foreign substance was found within the data port, the data port protective cover, and within the device.The composition and source of the substance is indeterminate, however it is consistent with fluid ingress.When plugged into the returned power cords the device produced a burnt odor and smoke, consistent with the customer complaint.Functional testing could not be performed as the unit did not turn on.

• Brand Name: V.A.C. FREEDOM¿ THERAPY (SYSTEM)
• Type of Device: OMP
• Manufacturer (Section D): KINETIC CONCEPTS, INC.; san antonio TX
• Manufacturer Contact: steven jackson ; 6203 farinon drive; san antonio, TX
• MDR Report Key: 7035631
• MDR Text Key: 93252305
• Report Number: 3009897021-2017-00113
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• PMA/PMN Number: K062227
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WNDFRE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2006
• 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