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

Model Number	66800951
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/24/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, after procedure when put batteries in pump and all of the lights came on, never turned off, and pump would not apply negative pressure.The procedure finished with a smith and nephew backup device.
Additional Manufacturer Narrative
We have now concluded our investigation for the complaint received.A review of the batch manufacturing records could not be performed as no part number was provided, however, there are no indications to suggest that the device did not meet specifications upon release into distribution.A complaint history review was carried out using the lot number provided, there have been further complaints reported with this failure mode in the past three years.The device was intended for use in treatment.The returned device was evaluated.A relationship between the event and the device was confirmed.An initial visual inspection did not identify any issues.When fresh batteries were inserted into the device all indicator lights were solidly illuminated and the device did not function.No performance data could be extracted from the device.Further investigation into this failure will be carried out with a cross functional team.The root cause remains undetermined.It is possible that a software issue caused the reported event.We will continue to monitor for any adverse trends relating to this product range.

• 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: 10550535
• Report Number: 8043484-2020-02892
• Device Sequence Number: 16892162
• Product Code: OMP
• UDI-Device Identifier: 05000223477073
• UDI-Public: 05000223477073
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2020

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 Model Number: 66800951
• Device Catalogue Number: 66800951
• Device Lot Number: 2002
• Initial Date Received by Manufacturer: 08/24/2020
• Supplement Date Received by Manufacturer: 10/02/2020
• Initial Report FDA Received Date: 09/17/2020
• Supplement Report FDA Received Date: 10/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1