MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. PICO SINGLE USE NPWT 10 X 20CM; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Model Number 66800951

Device Problem Device Inoperable (1663)

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

Event Date 11/29/2014

Event Type  malfunction  

Event Description

It was reported that pico dressing was put on patient and had a good seal, by day 4 the pump had stopped working, the green light was on but the dressing was not sucked down.Based on the limited information available to smith & nephew at this time, this event is deemed to be a device malfunction pursuant to 21 c.F.R.Part 803.3.

• Brand Name: PICO SINGLE USE NPWT 10 X 20CM
• Type of Device: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull; HU3 2 NB; UK HU3 2NB
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull; HU3 2 NB; UK HU3 2NB
• Manufacturer Contact: claudia odoy ; schachneallee 29; aarau; SZ 5001
• MDR Report Key: 4882773
• MDR Text Key: 5865269
• Report Number: 8043484-2015-00057
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K112127
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/02/2014

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: 66800951
• Device Catalogue Number: 66800951
• Device Lot Number: BQDBJ075
• Other Device ID Number: BQDBJ075
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2014
• Initial Date FDA Received: 07/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention