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

Model Number INFOVAC

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Consequences Or Impact To Patient (2199)

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 a second 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 feb 2 2016, kci quality engineering conducted a visual examination of the returned device and power cord which determined there was extensive damage to the lithium battery pack, the battery housing, and the charging section of the therapy board.The returned power cord was also damaged.There was burn damage to the back of the device.The visible burn damage provides evidence that a heat event occurred resulting in damage to external device components.A root cause investigation is in progress.

Manufacturer Narrative

Based on the information provided, kci has confirmed the allegation of a heat event and determined this event is reportable due to possible use error.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 (page 57) 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 30 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 damage to the unit's lithium battery pack, with corresponding black residue and thermal damage to the housing, battery tray, pcb therapy board and returned ac power cord.A radiographic and electrical inspection indicated charring of the pcb therapy board, which was superficial and secondary to the initial failure.The heat event associated with this device was determined to be due to failure of the lithium-ion battery, with chlorine contamination (from fluid ingress) contributing to failure through corrosion of the battery's regulator circuit board and/or battery cell(s).The customer complaint was confirmed by kci qe.

• 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: 5405788
• MDR Text Key: 37343174
• Report Number: 3009897021-2016-00010
• 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: 07/22/2016

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: 07/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2008
• 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