MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. PICO 14 15CM X 15CM US CTN1; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Catalog Number	66022045
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during npwt, the pico 14 15cm x 15cm pump had all four lights stay lit.The treatment was completed with another pump.No patient injury or other complications were reported.
Additional Manufacturer Narrative
H10.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.The loss of negative pressure wound therapy due to an inoperative or 'stopped' pump will not directly cause or contribute to serious injury or death as the pico dressing can revert to managing the wound as a standard multilayer dressing.No risk to patient safety is anticipated.This event is considered not reportable pursuant to 21 cfr part 803.

• Brand Name: PICO 14 15CM X 15CM US CTN1
• 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: 12059409
• Report Number: 8043484-2021-01575
• Device Sequence Number: 3775055
• Product Code: OMP
• UDI-Device Identifier: 05000223495411
• UDI-Public: 5000223495411
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K191760
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2021

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 Expiration Date: 12/01/2021
• Device Catalogue Number: 66022045
• Device Lot Number: 1950
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/11/2021
• Supplement Date Received by Manufacturer: 08/04/2021
• Initial Report FDA Received Date: 06/24/2021
• Supplement Report FDA Received Date: 08/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1