MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. PICO SINGLE USE NPWT 15 X 15CM; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Model Number	66800954
Medical Device Problem Codes	Pumping Stopped (1503); Defective Device (2588)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the pump did not work when it was taken out of the box and all the lights were flashing.No case reported; therefore, there was no patient involvement.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
We have now completed our investigation into the reported complaint.A review of the batch manufacturing records could not be performed as no lot number was provided, however, there are no indications to suggest that the device did not meet specifications upon release into distribution.The complaint history file contains further instances/ related events of the reported event.As no product could be returned, a thorough evaluation of the device could not be carried out.The device was intended for use in treatment.It was reported that all indicator lights were solidly illuminated.This means that the device entered a non-recoverable error state.There are various reasons that the device may enter an error state, such as out of range negative pressure, out of range power supply and an error retrieving data.If the pump does enter an error state, it must be replaced.This is a patient safety feature.We have not been able to confirm a relationship between the event and the device or identify a definitive root cause.No further actions by smith and nephew 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 15 X 15CM
• 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: 10872269
• Report Number: 8043484-2020-03946
• Device Sequence Number: 17078255
• Product Code: OMP
• UDI-Device Identifier: 05000223477134
• UDI-Public: 05000223477134
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K180698
• 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): 12/11/2020

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: No Information
• Device Model Number: 66800954
• Device Catalogue Number: 66800954
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/27/2020
• Supplement Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 11/19/2020
• Supplement Report FDA Received Date: 12/11/2020
• Patient Sequence Number: 1