MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. PICO 7 15CMX15CM; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Model Number	66022005
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference number: (b)(4).
Event or Problem Description
It was reported that the pico pump does not work.It has all alarm lights on and the green ok is also on constantly.This was brand new pump and not a used pump.There was no patient involved.
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.The complaint history file contains further instances/related events of the reported event.The device was intended for use in treatment.The returned device was evaluated.An initial visual inspection did not identify any issues.When fresh batteries were inserted into the device, the device functioned without issue.Device performance data shows the device ran for under 10 minutes.No errors or issues were identified.If the ifu is not directly followed, the delivery of effective negative pressure wound therapy may be impacted.We have not been able to confirm, a relationship between the event and the device.The investigation has been concluded, as ¿no device problem identified¿.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 7 15CMX15CM
• 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: 11336297
• Report Number: 8043484-2021-00349
• Device Sequence Number: 19038391
• Product Code: OMP
• UDI-Device Identifier: 05000223492205
• UDI-Public: 05000223492205
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K180698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2021

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 Model Number: 66022005
• Device Catalogue Number: 66022005
• Device Lot Number: 2003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2021
• Initial Date Received by Manufacturer: 01/27/2021
• Supplement Date Received by Manufacturer: 04/16/2021
• Initial Report FDA Received Date: 02/17/2021
• Supplement Report FDA Received Date: 04/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1