MAUDE Adverse Event Report: KCI USA, INC. PREVENA¿ 125 THERAPY UNIT; OMP

Model Number WNDPRV

Device Problems Smoking (1585); Device Issue (2379); Battery Problem (2885)

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

Event Date 02/23/2017

Event Type  malfunction  

Manufacturer Narrative

Based on information provided, kci is reporting this event per preliminary review of images provided.It was confirmed no harm or injury occurred to the patient or clinicians.Device evaluation in progress.

Event Description

On feb 24 2017, the following information was reported to kci by kci representative: a prevena¿ 125 therapy unit was reportedly "making a knocking noise, had smoke and burn internals around the batteries." no injuries were reported.On mar 01 2017, the following information was reported to kci by kci representative: "i confirmed with risk management no harm to patient or clinicians.The unit was replace with another one, and no negative outcome was reported." on mar 23 2017, kci received the following information via medwatch (mw5068321): "prevena incision management system overheated while attached to a patient.The patient reported hearing popping and then saw smoke.He immediately called for nurse.When nurses arrived, they smelled an electrical burning odor and saw smoke and soot on the patient's sheets.No harm occurred to the patient.The device was attached to the patient's abdominal incision." the event date was noted as (b)(6) 2017.A preliminary review of images provided exhibited evidence of a heat event.A follow up mdr will be submitted once the device evaluation has been completed.

Manufacturer Narrative

Based on the additional information obtained regarding the device, kci's assessment remains the same; kci reported this event based on review of images provided.It was confirmed no harm or injury occurred to the patient or clinicians.Device evaluation in progress.

Event Description

On (b)(6) 2017, kci quality engineering reviewed the images provided which exhibited evidence of thermal damage with corresponding black residue and smoke damage in the battery tray.Damage was noted to one of three batteries such that the unit would no longer operate.On (b)(6) 2017, the prevena¿ 125 therapy unit was returned to kci.A device evaluation of the prevena¿ 125 therapy unit is currently pending completion.On (b)(6) 2017, a device history review of lot number 2997903 was performed and determined that there were no issues during the manufacturing or servicing of this unit that would have lead to the reporting event.

Manufacturer Narrative

Based on the additional information obtained regarding the device, kci determined that despite visual examination of the prevena¿ 125 therapy unit by kci quality engineering verifying damage consistent with a thermal event, further investigation did not provide any evidence of a unit malfunction or prevena component failure.Inspection revealed thermal damage to one of the unit's lithium batteries.This event has been reported to the manufacturer of the associated lithium batteries.It was confirmed no harm or injury occurred to the patient or clinicians.

Event Description

The occurrence of a thermal event was verified by kci quality engineering in association with one of the off the shelf lithium batteries.While the prevena device did sustain resulting physical damage to its housing, there was no fault found with the device or its circuitry.The prevena unit functioned properly as designed and did not get warm when powered utilizing an external power source.While one of the lithium batteries was damaged and defunct, the remaining two batteries were verified to retain proper voltage and to function properly during extended test run installed in a prevena control unit.Based upon the kci engineering evaluation, no electrical anomalies or faults can be confirmed associated with the prevena device.This event has been reported to the manufacturer of the associated lithium batteries for further analysis.(b)(4) this event has been reported to the manufacturer of the associated lithium batteries for further analysis.(b)(4).

Manufacturer Narrative

Based on the additional information obtained from energizer's lithium battery analysis, kci's assessment remains the same; it was determined that despite visual examination of the prevena¿ 125 therapy unit by kci quality engineering verifying damage consistent with a thermal event, further investigation did not provide any evidence of a unit malfunction or prevena component failure.Inspection revealed thermal damage to one of the unit's lithium batteries.Energizer's analysis revealed evidence that the battery heated and vented due to an internal short circuit.The cause of the internal short circuit in the battery is indeterminate.

Event Description

On 01 aug 2017, kci received energizer's manufacturer complaint reference (b)(4) analysis of the associated lithium batteries which reported the following: "we [energizer] suspect that the battery heated and vented due to an internal short circuit.The short may have been the result of a dented can.It is indeterminable how, where or when the denting occurred, if that is indeed the cause of the short.When the battery discharges, internal components slightly expand and in this case, the expansion and the dent likely led to the internal short circuit.Despite this incident being rare, and our lack of knowledge as to how or why the denting was present, in abundance of caution, energizer has alerted the manufacturing facility of this incident.".

• Brand Name: PREVENA¿ 125 THERAPY UNIT
• 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: 6432008
• MDR Text Key: 70909889
• Report Number: 3009897021-2017-00040
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 00849554000001
• UDI-Public: 0100849554000001102997903
• Combination Product (y/n): N
• PMA/PMN Number: K100821
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WNDPRV
• Device Lot Number: 2997903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization