MAUDE Adverse Event Report: SMITH & NEPHEW WOUND MANAGEMENT RENASYS GO NPWT DEVICE; PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)

Model Number 66800164

Device Problems Device Alarm System (1012); Break (1069)

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

Event Date 12/22/2011

Event Type  malfunction  

Event Description

Failure to alarm pump not alarming when seal broken.

Manufacturer Narrative

We are submitting one (1) initial, 30 day report, medwatch fda form 3500a, for a purported device malfunction which occurred while using the renasys ez.The issue of failure to alarm was confirmed upon evaluation of the returned device, which had a malfunctioning main circuit board.This could potentially be the root cause of the failure to alarm for leak.Additionally, the device was found to be odorous.The device was treated for odor and the main circuit board replaced.The complaint indicates that no harm to the patient was associated with this event.Smith & nephew will continue to monitor, track & trend similar complaints, and initiate additional investigations and corrective actions when and where deemed necessary.Smith & nephew has issued (b)(4) to initiate renasys product labeling updates.These labelling updates will provide enhanced information on the functionality of the alarms as they relate to the design of the device, and scenarios that can occur in clinical settings which may impact alarm functionality.

• Brand Name: RENASYS GO NPWT DEVICE
• Type of Device: PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)
• Manufacturer (Section D): SMITH & NEPHEW WOUND MANAGEMENT; 970 lake carillon drive; suite 110; st. petersburg FL 33716
• Manufacturer (Section G): SMITH & NEPHEW WOUND MANAGEMENT; 970 lake carillon drive; suite 110; st. petersburg FL 33716
• Manufacturer Contact: terry mcmahon ; 970 lake carillon drive; suite 110; st. petersburg, FL 33716 ; 7273993785
• MDR Report Key: 3769844
• MDR Text Key: 20788404
• Report Number: 3006760724-2014-00307
• Device Sequence Number: 1
• Product Code: BTA
• Combination Product (y/n): N
• PMA/PMN Number: K083375
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 66800164
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/05/2012
• Event Location: Hospital
• Date Manufacturer Received: 01/05/2012
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1