MAUDE Adverse Event Report: KCI USA, INC. INFOV.A.C.® THERAPY; OMP

Model Number INFOVAC

Device Problems Thermal Decomposition of Device (1071); Melted (1385); Device Emits Odor (1425)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 01/03/2016

Event Type  malfunction  

Manufacturer Narrative

Kci has insufficient information at this time to determine any potential root cause.Further evaluation of the unit is in progress.

Event Description

On (b)(6) 2016, the following information was reported to the kci by the operations manager from a rehab facility: on (b)(6) 2016, the on-call technician smelled smoke and found an infov.A.C.® unit in their storage room that had damage that looked like it had caught fire.The unit looked melted and had a burned area on the outside.The technician did not see an actual fire occur.The unit was located in their storage area and was plugged into a power strip at the time of event.There was no harm or injury to anyone.On (b)(6) 2016, kci quality engineering conducted a visual examination of the device and power cord.There was burn damage found at the top of unit.The returned ac power cord was also damaged.The graphical user interface (gui), therapy boards, and battery were all visibly in good condition.The burned area at the top of the unit and the severe damage of the ac power cord provide evidence that a heat event occurred.A root cause investigation is in progress.

Manufacturer Narrative

Based on the information provided, kci has determined this event is not reportable.Device labeling, available in print and online, states: -before preparing the infov.A.C.® therapy unit for use, inspect the unit for any damage or contamination.Refer to the care and cleaning chapter of the manual for more information.- ensure that the infov.A.C.® therapy unit and its power supply are not connected to ac power when using cleaning fluids of any nature.-kci recommends the following regarding cleaning and disinfecting kci v.A.C.® therapy devices.- to help reduce risk of infection and contact with blood and body fluids, use personal protective equipment (ppe) such as medical procedure gloves.- clean all organic material (visible soil or body secretions) from the therapy unit prior to disinfection.- use hospital-grade cleaner and disinfectants.- do not immerse or saturate the therapy unit with fluid to avoid damage to the electronics in the device.- do not use alcohol based solutions around the touchscreen edges or near gasket and power switches since alcohol solutions will easily wick up into the screen and may cause equipment malfunction.- fluids 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.If spills do occur, unplug the unit immediately and clean with an absorbent cloth.Ensure there is no moisture in or near the power connections and power supply components before reconnecting power.If the product does not work properly, contact kci.- do not use the product while bathing/showering or when it can fall or be pulled into a tub, shower or sink.- do not reach for a product that has fallen into water.Unplug the unit immediately if plugged into electrical source.Disconnect the unit from dressing and contact kci.- avoid spilling fluids on any part of the infov.A.C.® therapy unit.- keep the infov.A.C.® therapy system away from heated surfaces.

Event Description

On mar 31 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 jan 28 2016, the device was received and forwarded to kci quality engineering (qe) for evaluation.The post placement evaluation confirmed there was thermal damage to the unit and ac power cord, but an internal inspection of the device did not reveal any damage or malfunction that may have caused or contributed to the reported heat event.The unit's internal circuit boards and lithium battery pack were all found in good condition and showed no damage under radiographic inspection.Operational testing of the original battery pack in a known good device confirmed the battery pack functioned properly as designed with no damage.The evaluation indicated there was no failure originating with the device or its associated power cords that would have resulted in a sustainable fire where flames and smoke occurred.No electrical anomalies were noted in the device or dc power supply, which indicated the damage sustained by the device, was due to an external heat source, there was no fault found with this device to confirm the customer complaint.

• Brand Name: INFOV.A.C.® 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: 5405776
• MDR Text Key: 37733606
• Report Number: 3009897021-2016-00009
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/21/2016

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
• Device Operator: No Information
• Device Model Number: INFOVAC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/04/2016
• Initial Date FDA Received: 02/02/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2007
• 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