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

Model Number	WNDFRE
Medical Device Problem Codes	Temperature Problem (3022); Misassembly During Maintenance/Repair (4054)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During the repair process, kci found evidence that the device had thermal damage to the external and internal housing as well as damage to the compressor cable.The cause and timing of the damage is indeterminate.There is no patient involvement and there is no injury reported to kci associated with this event.Kci is reporting this event found during servicing of the unit as a device malfunction that has the potential to result in injury if the malfunction were to recur.Additional investigation of the device is in progress.Device labeling, available in print, states: in order for kci products to provide safe and proper performance: the electrical installation of the room must comply with the appropriate 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 the standard iec 60601-1-2 in relation to the electromagnetic compatibility, all electrical equipment may produce interference.If interference is suspected, separate the equipment and contact kci.Avoid spilling fluids on any part of the v.A.C.Freedom¿ therapy unit.Liquids 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 v.A.C.Freedom¿ therapy unit does not work properly, contact kci.Do not use v.A.C.Freedom¿ therapy unit 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.
Event or Problem Description
On 05-nov-2020, kci identified the v.A.C.Freedom¿ therapy system had thermal damage to internal components.There was no patient involvement or injury associated with this event.Kci quality engineering evaluated the device and determined the unit's housing revealed black residue both internal and external to the device.Internal inspection of the device revealed thermal damage on the compressor cable.The battery was tested and functioned as expected.Functional testing of the pump could not be performed.Additional investigation of the device is in progress.
Event or Problem Description
On 26-may-2021, the investigation of the device was completed.Per review by a kci engineer, it was determined the thermal damage to the compressor cable, board and housing were a result of the cables being pinched after being incorrectly routed in assembly.A melted transistor was also found during review.The cause and timing of the melted transistor is indeterminate.
Additional Manufacturer Narrative
Based on the additional information obtained regarding the device, it was determined the thermal damage resulted from the cables being pinched after being incorrectly routed.The cause and timing of the melted transistor is indeterminate.There was no patient involvement and there was no injury reported to kci associated with this event.Kci reported this event as a device malfunction that has the potential to result in injury if the malfunction were to recur.

• Brand Name: V.A.C. FREEDOM THERAPY SYSTEM
• Common Device Name: OMP
• Manufacturer (Section D): KINETIC CONCEPTS, INC.; san antonio TX 78249
• MDR Report Key: 10955506
• Report Number: 3009897021-2020-01048
• Device Sequence Number: 19377645
• Product Code: OMP
• UDI-Device Identifier: 00849554006539
• UDI-Public: 0100849554006539
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K120033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: WNDFRE
• Device Catalogue Number: 320001
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/05/2020
• Supplement Date Received by Manufacturer: 05/26/2021
• Initial Report FDA Received Date: 12/05/2020
• Supplement Report FDA Received Date: 06/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1