MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. PICO 7 20CM X 20CM; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Catalog Number	66802008
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a pico 7 have all the lights lit.They don`t go out and it`s not possible to start the treatment or turn off the pump.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The device, intended for use in treatment, has been returned and evaluated, establishing a relationship with the reported event.A functional evaluation was carried out.When fresh batteries were inserted, all indicator lights were solidly illuminated.Device performance data shows the device entered a non-recoverable error state after functioning for 116 hours.The device entered an nre state as the motor current was out of range, with the root cause established as a component failure.A review of the associated batch manufacturing records confirmed that the device met manufacturing specifications at the point of release.The complaint history review found further instances of the reported event in the past years.This investigation is now complete with no further action deemed necessary.Smith + nephew will continue to monitor for any adverse trends relating to this product range.Smith + nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.D1 & d4 updated.

• Brand Name: PICO 7 20CM X 20CM
• 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: 10820221
• Report Number: 8043484-2020-03831
• Device Sequence Number: 1127353
• Product Code: OMP
• UDI-Device Identifier: 05000223477073
• UDI-Public: 5000223477073
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K111170
• 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): 03/17/2021

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: 66802008
• Device Lot Number: 201947
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2020
• Initial Date Received by Manufacturer: 10/20/2020
• Supplement Date Received by Manufacturer: 03/03/2021
• Initial Report FDA Received Date: 11/10/2020
• Supplement Report FDA Received Date: 03/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1