‡ In these countries please contact our distributor

NPWT Complaints Form

Welcome to the New Zealand Smith & Nephew NPWT complaints registry.

Please fill out all areas of the form and click on the submit button at the end.

Was Patient Involved?
Was this an Out-Of-Box failure?*
Was the problem noted before, during or after the procedure?

Was the patient anethetised at the time?
Did the problem result in a patient injury/ harm/ hazard?*
Was a backup device available?

Did any pieces break off inside the wound?

Was the piece removed?
Will the device or a sample be returned for evaluation?

Is the device under warranty?
Are there any supporting images, surgical reports etc? If yes, please send all to the RA/QA coordinator
Which advanced wound device was used?*
Device Type
Software Version
Did the device fail during wound therapy?

Was the unit on battery or main power?
Did a LOW Battery alarm sound?
Low battery alarm will not resolve?
Did battery fail to charge?
Was the device in storage before use?
What dressing Kit was being used when issue occurred?

Were the components used in accordance with the IFU

Was there a modification in dressing application technique?

Was it compressed?

Was there any pooling or fluid beneath the dressing/ wound filler

Was the dressing compromised in any other manner (lifting off or not fully adhering)?
Canister Type:

What is the canister issue?

Was the issue resolved?
Was there an observable blockage present within the system?
Was there any observable frank bleeding visible in the tubing, dressing or under the wound filler?
Drainage amount

Was the patient taking medications at the time of the incident?
Did the patient have any of the conditions identified as precautions/contraindications on the IFU?
Were any precautionary measures taken prior to or during therapy based on the type of wound being treated or any patient conditions identified?
Was there a change in wound status and/or deterioration?
Was any medical or surgical intervention necessary as a result of the incident? *
Any other follow-up or additional information needed?
Was any part of the dressing raisin-like/firm to the touch/intact?
Was a contact layer being used?
Did any alarms sound?
Was the issue resolved?

If gauze was used, was switching to foam a viable option?
Trouble shooting Leak Alarm Function: With device running, clamp opened and cap off, was drain tubing disconnected from canister tubing to check status of leak alarm?
Did Blockage alarm sound?
Were clamps open?
Was canister full?
Was the tubing occluded?
Was the occlusion able to be removed? (i.e. milking the tubing, changing the canister)
Was the T-Piece visibly soiled or moistened?
Was exudate properly gelled by solidifier?
Was the canister filter wet?
If canister replaced, was the problem resolved?
With clamp closed, did leak alarm resolve?
If the dressing was not the source of the leak, was the tubing crimped or clamped between the T-Piece and the Quick Click connector to determine if the leak was at the Quick Click connection?