MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. PICO SINGLE USE NPWT 10X20CM; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Catalog Number	66800951
Medical Device Problem Code	Pumping Problem (3016)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/04/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during treatment the device turned on all the lights, stopped having pressure and did not work anymore, problem appeared suddenly.It is unknown how treatment was completed.No patient harm reported.
Additional Manufacturer Narrative
We have now concluded our investigation for the complaint received.A review of the associated batch manufacturing records did not identify any issue at the point of manufacture which may have caused or contributed to the issue highlighted by the complainant.In addition it can be confirmed that all finished product specification testing was satisfied at the point of release.A complaint history review was carried out using the lot and part numbers provided, there have been no further complaints reported with this failure mode in the past three years.The device was used for treatment.As the device was not returned we were not able to carry out a product evaluation.It was reported that the device turned on all lights and stopped applying pressure.It is possible that the device entered a non-recoverable error state.There are a number of reasons why a device may enter this state.This is a patient safety feature.We have not been able to confirm a relationship between the event and the device.We have not been able to determine a definitive root cause.No further actions are deemed necessary at this stage.However, we will continue to monitor for any adverse trends relating to this product range.Smith and nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.

• Brand Name: PICO SINGLE USE NPWT 10X20CM
• Common Device Name: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• MDR Report Key: 10084844
• Report Number: 8043484-2020-00529
• Device Sequence Number: 3696762
• Product Code: OMP
• UDI-Device Identifier: 05000223477073
• UDI-Public: 5000223477073
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2020

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: Health Professional
• Device Catalogue Number: 66800951
• Device Lot Number: 201919
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/27/2020
• Initial Date Received by Manufacturer: 04/27/2020
• Supplement Date Received by Manufacturer: 07/02/2020
• Initial Report FDA Received Date: 05/24/2020
• Supplement Report FDA Received Date: 07/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1