MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. PICO SINGLE USE NPWT 10 X 30CM; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Model Number 66800952

Device Problems Pumping Stopped (1503); Device Inoperable (1663)

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

Event Date 01/26/2017

Event Type  malfunction  

Event Description

Pumping stopped pico was applied on (b)(6) and stopped functioning within 24 hours.Device would not respond to button commands - replacement batteries were even attempted with no success.

• Brand Name: PICO SINGLE USE NPWT 10 X 30CM
• Type of Device: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: claudia de santis ; schachenallee 29; aarau 5001 ; SZ 5001 ; 0628320660
• MDR Report Key: 6363747
• MDR Text Key: 68971377
• Report Number: 8043484-2017-00074
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112127
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/08/2017

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
• Device Operator: Lay User/Patient
• Device Model Number: 66800952
• Device Catalogue Number: 66800952
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2017
• Initial Date FDA Received: 02/28/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1