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

Catalog Number UNKNOWN

Device Problem Pumping Problem (3016)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/15/2019

Event Type  malfunction  

Event Description

It was reported that during treatment pico 7 device that was dropped in the water stopped functioning.The green ok light is illuminated but so are the other light indicators- solidly illuminating orange and no suctioning heard.Back up device was available.No patient harm reported.The device cannot be returned for evaluation.

Manufacturer Narrative

We have now concluded our investigation into this complaint.Prior to manufacturing, all pico pumps undergo full functionality testing to an agreed specification.This ensures that all pumps are working correctly before being shipped to our customers; any failures identified are segregated for investigation.As no samples were returned, a visual and functional evaluation could not be carried out.At this time an exact root cause cannot be determined.If additional information becomes available in the future, this case will be reopened.Smith and nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.We will continue to monitor for any adverse trends relating to this product range.

• Brand Name: PICO 7
• Type of Device: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull ; UK
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: sarah freestone ; 101 hessle road; hull ; UK ; 0447940038
• MDR Report Key: 8892514
• MDR Text Key: 154291720
• Report Number: 8043484-2019-00575
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/29/2019

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/15/2019
• Initial Date FDA Received: 08/14/2019
• Supplement Dates Manufacturer Received: 07/15/2019
• Supplement Dates FDA Received: 08/29/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1