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

Device Problems No Audible Alarm (1019); Device Inoperable (1663)

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

Event Date 01/30/2017

Event Type  malfunction  

Event Description

It was reported that the device stopped working the same day it was applied.The lights stopped flashing and there was no sound.The batteries were changed out with no success.

• Brand Name: NPWT PICO
• 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; spa park; hull HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: claudia desantis ; schachenallee 29; aarau 5001 ; SZ 5001
• MDR Report Key: 6375674
• MDR Text Key: 69017816
• Report Number: 8043484-2017-00078
• 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: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 03/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/02/2017
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1