MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. PICO 7 10CMX40CM; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Model Number	66022004
Medical Device Problem Code	Suction Failure (4039)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during npwt, a pico 7 10cmx40cm system was unable to make proper seal.No significant delay in treatment due to this malfunction was reported; nevertheless, treatment was concluded with a competitors dressing.Neither patient injury nor other complications were reported.
Additional Manufacturer Narrative
The information received by the manufacturer has been re-evaluated for mdr reporting and it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• Brand Name: PICO 7 10CMX40CM
• 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: 11853534
• Report Number: 8043484-2021-01182
• Device Sequence Number: 3847026
• Product Code: OMP
• UDI-Device Identifier: 05000223492199
• UDI-Public: 05000223492199
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/01/2022
• Device Model Number: 66022004
• Device Catalogue Number: 66022004
• Device Lot Number: 2039
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/04/2021
• Supplement Date Received by Manufacturer: 09/23/2021
• Initial Report FDA Received Date: 05/20/2021
• Supplement Report FDA Received Date: 09/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention